Dexmedetomidine and Its Influence on Extubation Outcomes: A Prospective Randomized Double-Blind Study

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Journal of MedVerse Research & Practice

ISSN: 3107-4278

Dexmedetomidine and Its Influence on Extubation Outcomes: A

Prospective Randomized Double-Blind Study

Dr. Keerthana P

, Dr. Geetha Priya S

Postgraduate, Associate Professor

Department of Anesthesiology, Coimbatore Medical College and Hospital

Email: skeerthana@gmail.com

Submission Date: 22.05.2025

Accepted Date: 20.06.2025

Published Date: 30.06.2025

DOI: 10.65188/nurexus.1028

article distributed under the terms of the Creative Commons Attribution License (CC BY 4.0), which permits

unrestricted use, distribution, and reproduction in any medium, provided the original author(s) and source are credited.

Abstract

Background: Extubation following general anaesthesia is often associated with undesirable airway and

hemodynamic responses, such as coughing, hypertension, tachycardia, and agitation, which may lead to

complications, especially in vulnerable patients. Dexmedetomidine, a selective alpha-2 adrenergic agonist, has shown

potential in attenuating these responses while providing stable sedation and cardiovascular control.

Aim: To assess the effect of intravenous dexmedetomidine on the quality and ease of extubation in adult patients

undergoing elective surgeries under general anaesthesia.

Materials and Methods: This prospective, randomized, double-blind study was conducted in the Department of

Anaesthesiology at a tertiary care hospital over one year. Seventy-five patients (ASA I–II), aged 18–60 years,

scheduled for elective surgeries under general anaesthesia, were randomly allocated into two groups. Group D

received dexmedetomidine 0.5 µg/kg IV over 10 minutes before extubation; Group C received normal saline.

Extubation quality (cough score), ease of extubation, hemodynamic parameters, sedation level (Ramsay Sedation

Scale), time to extubation, and adverse events were recorded and analysed.

Results: Group D showed significantly improved extubation profiles. The incidence of severe coughing was lower in

Group D (5.2%) compared to Group C (29.8%) (p < 0.001). Easy extubation was observed in 84.2% of patients in

Group D versus 40.5% in Group C. Hemodynamic parameters (HR and MAP) were significantly more stable in the

dexmedetomidine group post-extubation (p < 0.001). Sedation scores were higher in Group D without delaying

recovery (p = 0.187). Adverse effects were minimal and not statistically significant.

Conclusion: Intravenous dexmedetomidine at a dose of 0.5 µg/kg significantly improves extubation quality and

hemodynamic stability without delaying emergence or causing major side effects. It is a safe and effective agent for

smooth extubation in elective surgical settings.

Keywords: Dexmedetomidine, Extubation, Cough Reflex, Hemodynamic Stability, General Anaesthesia, Ramsay

Sedation Scale, Randomized Controlled Trial

Introduction

The process of tracheal extubation represents a crucial transition during general anaesthesia and is

frequently associated with undesirable physiological responses such as elevated heart rate, hypertension,

coughing, restlessness, and, in some cases, complications like laryngospasm or bronchospasm [1,2]. These

reactions stem primarily from the stimulation of airway reflexes during endotracheal tube removal and can

lead to complications, especially in patients with pre-existing cardiac or neurological issues [3]. Therefore,

achieving a calm and controlled extubation is a key objective in perioperative anaesthetic management.

To attenuate these extubation-related responses, several pharmacological interventions have been explored,

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including opioids, beta-blockers, local anaesthetics such as lidocaine, and alpha-2 adrenergic agonists [4].

Among these, dexmedetomidine, a selective alpha-2 adrenoceptor agonist, has gained clinical interest due

to its sedative, analgesic, and sympatholytic effects, all achieved without significantly affecting respiratory

drive [5]. These properties make it an effective choice for blunting airway reflexes and stabilizing

hemodynamics during the emergence phase.

Multiple studies have highlighted dexmedetomidine’s role in minimizing coughing, agitation, and

emergence delirium during recovery from general anaesthesia in both adult and paediatric populations

[6,7]. Additionally, its use has been associated with reduced fluctuations in heart rate and arterial pressure

during extubation, thereby improving cardiovascular stability [8]. It also provides a unique sedation profile

characterized by a calm yet arousable state, offering a practical advantage during the extubation phase [9].

Randomized trials and meta-analyses have consistently demonstrated dexmedetomidine’s effectiveness in

enhancing extubation outcomes and have compared it favorably with drugs like fentanyl and propofol

[10,11]. Nonetheless, variations in patient selection, surgical procedures, and dosing regimens across

studies warrant further investigation through structured, double-blind, randomized controlled trials.

This study was designed to evaluate the impact of dexmedetomidine on the quality and ease of extubation

in patients undergoing elective surgeries under general anaesthesia. The primary endpoints included the

incidence of coughing, agitation, and hemodynamic changes during and shortly after extubation. Secondary

endpoints focused on sedation levels, recovery time, and potential adverse effects following drug

administration. Understanding the role of dexmedetomidine in this context may offer valuable insights into

improving peri-extubation care and enhancing overall patient safety and comfort during recovery.

Materials & Methods

This study was designed as a prospective, randomized, double-blind, controlled trial conducted over a

period of one year in the Department of Anaesthesiology, Coimbatore Medical College and Hospital, a

tertiary care teaching hospital located in Tamil Nadu, India. The study protocol was reviewed and approved

by the Institutional Ethics Committee (IEC) of Coimbatore Medical College. Written informed consent was

obtained from all patients after explaining the purpose, procedure, risks, and benefits of the study in their

local language.

A total of 75 adult patients were included in the study. The sample size was calculated based on previous

studies demonstrating a significant difference in the incidence of extubation-related complications using

dexmedetomidine, considering a confidence level of 95% and power of 80%. Inclusion Criteria: Patients

aged 18–60 years, ASA Physical Status I or II, scheduled for elective surgeries under general anaesthesia

requiring endotracheal intubation, anticipated surgical duration between 1 to 3 hours. Exclusion Criteria:

Patients with known allergy to dexmedetomidine, Severe cardiovascular, hepatic, renal or respiratory

diseases, History of bradyarrhythmia or patients on beta-blockers or clonidine, Pregnant or lactating

women, Patients with an anticipated difficult airway.

Randomization and Blinding: Patients were randomly allocated into two groups (Group D and Group C)

using computer-generated randomization tables. Allocation concealment was ensured using sealed opaque

envelopes. Group D (Dexmedetomidine group) received intravenous dexmedetomidine at a dose of 0.5

µg/kg over 10 minutes, 10 minutes prior to the anticipated extubation. Group C (Control group) received an

equivalent volume of normal saline over the same time period. Both the anaesthesiologist administering the

drug and the observer recording the extubation parameters were blinded to the group allocation.

Anaesthesia Protocol: All patients were premedicated with Inj. midazolam 0.03 mg/kg IV and Inj.

glycopyrrolate 0.004 mg/kg IV. Induction was performed with propofol 2 mg/kg, fentanyl 2 µg/kg, and

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vecuronium 0.1 mg/kg to facilitate endotracheal intubation. Anaesthesia was maintained with oxygen,

nitrous oxide, and isoflurane. Neuromuscular blockade was maintained with intermittent doses of

vecuronium as required. Standard intraoperative monitoring (ECG, SpO₂, NIBP, EtCO₂) was performed

throughout the procedure. Towards the end of surgery, all inhalational agents were discontinued, and

neuromuscular blockade was reversed with neostigmine 0.05 mg/kg and glycopyrrolate 0.01 mg/kg IV. The

study drug (dexmedetomidine or normal saline) was administered 10 minutes prior to planned extubation.

Outcome Measures

Primary Outcomes:

Quality of extubation, assessed using a 4-point cough score:

0 = No cough

1 = Minimal (1–2) non-sustained coughs

2 = Moderate (3–4) coughs

3 = Severe (≥5) sustained coughs or bucking

Ease of extubation, assessed subjectively by the anaesthesiologist (Easy / Moderate / Difficult)

Secondary Outcomes:

• Hemodynamic parameters: Heart rate and blood pressure recorded at baseline, immediately before

and after extubation, and at 1, 3, and 5 minutes post-extubation

• Sedation score, assessed using the Ramsay Sedation Scale (RSS)

• Time to extubation (time from cessation of anaesthetic agents to removal of the endotracheal tube)

• Adverse events, such as bradycardia (HR < 50 bpm), hypotension (MAP < 60 mmHg), desaturation

(SpO₂ < 92%), or delayed awakening

The study obtained approval from the Institutional Ethics Committee of Coimbatore Medical College and

Hospital (Ref No: CMC/EC/2023/8421). A detailed Participant Information Sheet was provided to all

participants, and written informed consent was obtained prior to their participation in the study.

Statistical Analysis: Data were entered and analyzed using SPSS software version 26. Continuous

variables were expressed as mean ± standard deviation (SD) and compared using the Student’s t-test.

Categorical variables were presented as frequencies/percentages and compared using the Chi-square test or

Fisher’s exact test, as appropriate. A p-value < 0.05 was considered statistically significant.

Results

A total of 75 patients were enrolled and randomly divided into two groups:

• Group D (Dexmedetomidine): 38 patients

• Group C (Control/Normal Saline): 37 patients

No patients were excluded or lost to follow-up. The demographic and baseline parameters were comparable

between the groups.

Table 1: Demographic Characteristics

Parameter

Group D (n = 38)

Group C (n = 37)

p-value

Age (years)

42.3 ± 10.5

40.6 ± 11.2

0.48

Gender (M/F)

22 / 16

20 / 17

0.83

Weight (kg)

63.1 ± 9.6

61.7 ± 10.1

0.52

ASA Grade I/II

28 / 10

27 / 10

0.94

Duration of Surgery (min)

104.5 ± 20.8

102.1 ± 22.3

0.63

There was no statistically significant difference between the two groups in terms of age, gender

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distribution, body weight, ASA status, or surgical duration. This ensures that the groups were comparable

at baseline.

Table 2: Cough Score at Extubation

Cough Score

Group D (n = 38)

Group C (n = 37)

p-value

0 (No cough)

18 (47.4%)

4 (10.8%)

<0.001

1 (Mild)

12 (31.6%)

9 (24.3%)

2 (Moderate)

6 (15.8%)

13 (35.1%)

3 (Severe)

2 (5.2%)

11 (29.8%)

The dexmedetomidine group had significantly fewer coughing episodes during extubation (p < 0.001),

indicating better airway reflex control and smoother extubation.

Table 3: Ease of Extubation (Subjective Score)

Ease of Extubation

Group D (n = 38)

Group C (n = 37)

p-value

Easy

32 (84.2%)

15 (40.5%)

<0.001

Moderate

5 (13.2%)

13 (35.1%)

Difficult

1 (2.6%)

9 (24.3%)

A significantly higher proportion of patients in Group D had easy extubation, reinforcing

dexmedetomidine's effectiveness in facilitating a smoother emergence from anaesthesia.

Table 4: Hemodynamic Parameters at Extubation

Timepoint

HR (bpm) –

Group D

HR –

Group C

MAP (mmHg) –

Group D

MAP –

Group C

value

Baseline

78.6 ± 8.1

80.2 ± 7.5

93.4 ± 6.8

94.1 ± 7.1

>0.05

Immediately after

extubation

82.3 ± 9.3

95.7 ± 10.1

95.1 ± 8.6

106.5 ± 9.3

<0.001

5 min post-extubation

80.6 ± 8.2

92.4 ± 8.7

92.7 ± 6.1

102.3 ± 7.5

<0.001

Group D exhibited significantly lower heart rate and mean arterial pressure (MAP) at and after extubation,

indicating better hemodynamic stability.

Table 5: Sedation Score (Ramsay Sedation Scale) at Extubation

Sedation Score (RSS)

Group D (n = 38)

Group C (n = 37)

p-value

1 (Anxious/agitated)

0 (0%)

6 (16.2%)

0.032

2 (Cooperative)

24 (63.2%)

22 (59.5%)

3 (Responsive to command)

14 (36.8%)

9 (24.3%)

The patients in Group D were anxious or agitated (RSS = 1), whereas 16.2% in Group C were, which is

statistically significant (p = 0.032). Most patients in both groups were cooperative (RSS = 2). A higher

proportion in Group D were more sedated but still responsive to commands (RSS=3) compared to Group C.

Table 6: Time to Extubation

Parameter

Group D (n = 38)

Group C (n = 37)

p-value

Time to Extubation (min)

7.4 ± 2.1

6.9 ± 1.8

0.187

There was no statistically significant delay in time to extubation in the dexmedetomidine group, indicating

that the sedative effect did not prolong recovery.

Table 7: Adverse Events

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Adverse Event

Group D (n = 38)

Group C (n = 37)

p-value

Bradycardia

3 (7.9%)

1 (2.7%)

0.61

Hypotension

2 (5.3%)

1 (2.7%)

0.64

Desaturation (SpO₂ < 92%)

0 (0%)

2 (5.4%)

0.23

Nausea/Vomiting

1 (2.6%)

2 (5.4%)

0.59

No significant adverse events were noted in either group. Dexmedetomidine was well tolerated, with a

favorable safety profile.

Discussion

This randomized controlled trial investigated the impact of a single dose of intravenous dexmedetomidine

(0.5 µg/kg) on the quality and ease of extubation in patients undergoing elective surgical procedures under

general anaesthesia. Our study findings confirm that dexmedetomidine significantly enhances extubation

outcomes by minimizing airway irritation, ensuring hemodynamic stability, and maintaining an appropriate

level of sedation without delaying recovery or increasing serious adverse effects.

Extubation Quality

Nearly half of the patients in the dexmedetomidine group experienced no coughing, and only 5.2% had

severe coughing, compared to nearly 30% in the control group, indicating a highly significant improvement

(p < 0.001). This aligns closely with the observations of Guler et al., who found that dexmedetomidine

effectively reduced both coughing and agitation during emergence from anaesthesia [6]. Similarly, Agarwal

et al. demonstrated that dexmedetomidine could attenuate the stress responses associated with extubation

without inducing respiratory compromise [13].

The mechanism behind this benefit is likely due to dexmedetomidine’s central sympatholytic activity,

which leads to dampening of airway reflexes and suppression of laryngeal stimulation responses.

Ease of Extubation

Subjective evaluations by attending anaesthesiologists showed that a significantly higher number of

patients in the dexmedetomidine group had easy extubation (84.2%) compared to the control group

(40.5%). These findings support the results reported by Kumar et al., who observed smoother extubation

and more stable emergence profiles when dexmedetomidine was used [14].

Hemodynamic Stability

One of the notable advantages of dexmedetomidine observed in this study was the reduction in heart rate

and mean arterial pressure immediately and up to 5 minutes after extubation. The differences were

statistically significant and clinically meaningful. These findings are consistent with those reported by

Tufanogullari et al. and Lawrence and De Lange, both of whom noted that dexmedetomidine helps

maintain peri-extubation cardiovascular stability by reducing sympathetic outflow [15, 16].

Given that cardiovascular fluctuations during extubation can be detrimental in patients with comorbid

conditions, the attenuation of these changes makes dexmedetomidine a favorable option for high-risk

surgical populations.

Sedation and Recovery

Although sedation levels were higher in the dexmedetomidine group, the Ramsay Sedation Score indicated

that patients remained responsive to commands, indicating that the drug provided calm, cooperative

sedation without over-sedation or delayed emergence. These findings correlate with those from Bekker and

Sturaitis, who emphasized the benefits of dexmedetomidine in producing a desirable sedative state during

neurosurgical procedures [17]. El-Hakim et al. also observed that dexmedetomidine minimized emergence

agitation and improved extubation conditions in paediatric cardiac surgery [18].

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Importantly, there was no statistically significant prolongation in time to extubation, showing that the

sedative effect of dexmedetomidine does not compromise timely recovery.

Adverse Effects

In our study, mild bradycardia and hypotension were observed in a few patients in the dexmedetomidine

group, but these events were transient and did not require intervention, mirroring the results of

Abdelrahman and Mohamed [19]. There were no reports of respiratory depression, reffirming

dexmedetomidine’s safety in the context of airway management [20].

Comparison with Other Agents

Previous research has also compared dexmedetomidine to drugs like fentanyl, lidocaine, and propofol. For

instance, Yildiz et al. found dexmedetomidine to be superior to both esmolol and fentanyl in terms of

controlling hemodynamic responses and maintaining optimal sedation during extubation [21]. Similarly,

Tariq et al. observed that dexmedetomidine was more effective than lidocaine in reducing extubation-

related airway reactions and cardiovascular stress [22].

Limitations

The study sample was limited to ASA I–II patients undergoing elective surgeries; findings may not

extrapolate to emergency or high-risk populations. Extubation quality was partly based on subjective

assessment; objective tools such as video documentation or third-party scoring could enhance precision.

The study only assessed a single bolus dose; continuous infusion protocols could potentially yield different

results and warrant further research.

Conclusion

The present study demonstrates that intravenous dexmedetomidine at a dose of 0.5 µg/kg, administered

before extubation, significantly improves the quality and ease of extubation in adult patients undergoing

elective surgery under general anaesthesia. Dexmedetomidine was associated with a marked reduction in

coughing, better sedation levels, and superior hemodynamic stability during and after extubation, compared

to normal saline. Importantly, it did not cause delayed recovery or significant adverse effects, affirming its

safety and efficacy in the peri-extubation period. These findings support the use of dexmedetomidine as an

effective agent to facilitate smooth and controlled emergence from anaesthesia, particularly in settings

where minimizing airway and cardiovascular stress is clinically desirable. Further studies with larger

sample sizes and varied surgical populations are recommended to validate these results and optimize

dosage protocols for broader clinical application.

Conflict of Interest: Nil

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