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CTRI Number  CTRI/2024/09/074528 [Registered on: 30/09/2024] Trial Registered Prospectively
Last Modified On: 27/07/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Surgical/Anesthesia 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Comparison of Low-Dose Ketamine with Lignocaine vs. Dexmedetomidine for Safe and Comfortable Breathing Tube Placement in Patients with Difficult Airways 
Scientific Title of Study   Comparison of effect of Subanesthetic dose of Intravenous Ketamine + Lignocaine versus Intravenous Dexmedetomidine on the intubating conditions and hemodynamic stability in awake fiberoptic intubation for anticipated difficult airway: a randomized clinical study 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr. Tarun Ponugoti 
Designation  Junior Resident 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anesthesiology, 4th floor, B block, All India Institute of Medical Sciences, Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  9515195751  
Fax    
Email  tarunponugoti14@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr. Jitendra Kalbande 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anesthesiology, 4th floor, B block, All India Institute of Medical Sciences, Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  8368326094  
Fax    
Email  drjitu222@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr.Jitendra Kalbande 
Designation  Assistant Professor 
Affiliation  All India Institute of Medical Sciences 
Address  Department of Anesthesiology, 4th floor, B block, All India Institute of Medical Sciences, Raipur

Raipur
CHHATTISGARH
492099
India 
Phone  8368326094  
Fax    
Email  drjitu222@gmail.com  
 
Source of Monetary or Material Support  
Department of Anesthesiology, All India Institute of Medical Sciences, Raipur 
 
Primary Sponsor  
Name  Dr Tarun Ponugoti 
Address  Department of Anesthesiology, 4th floor, B block, All India Institute of Medical Sciences, Raipur 
Type of Sponsor  Other [Self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Tarun Ponugoti  All India Institute of Medical Sciences Raipur  Department of Anesthesiology, Operation theatre complex, B block, 4th floor
Raipur
CHHATTISGARH 
9515195751

tarunponugoti14@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O||Medical and Surgical, (2) ICD-10 Condition: T888||Other specified complications of surgical and medical care, not elsewhere classified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Dexmedetomidine  1 mcg/kg bolus over 10 mins intravenousfollowed by 0.2-0.7 mcg/kg/hr infusion intravenously until the procedure of fiberoptic intubation is completed 
Intervention  Ketamine, Lignocaine  Ketamine- 0.3 mg/kg bolus intravenous followed by 0.3 mg/kg/hr infusion intravenously until the procedure of fiberoptic intubation is completed Lignocaine- 1.5 mg/kg bolus intravenous followed by 1.5 mg/kg/hr infusion intravenously until the procedure of fiberoptic intubation is completed 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Patients posted for elective surgeries
2.Patients with ASA status of 1 and 2
3.Patients with Anticipated Difficult Airway with El‑Ganzouri Score
4–12 
 
ExclusionCriteria 
Details  1. Patients unwilling to give consent for the study
2. Patients with contraindications for awake fiberoptic intubation such as history of coagulopathies, base of skull fracture
3. Patients allergic to study medications
4. Patients with coexisting diseases like uncontrolled hypertension, asthma, history of MI,CAD, shock, heart blocks, heart failure
5. Pregnant women 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Intubating conditions in terms of Modified Observer Assessment of Alertness/Sedation(OAA/S) score,Endoscopy time, Intubation time, Endoscopist satisfaction score,Patient Discomfort score, Patient Recall of procedure  OAA/S score-Immediately before intubation
Endoscopy time-from insertion of scope to carina visualization
Intubation Time-from ET tube insertion to fiberscope is removed
Endoscopist satisfaction-immediately after intubation
Patient Discomfort score- During intubation
Patient recall- 24 hours postoperatively 
 
Secondary Outcome  
Outcome  TimePoints 
Hemodynamic Parameters(Heart rate, Mean Arterial Pressure, Oxygen Saturation)  Baseline, after achieving desired sedation level, 1 minute intervals during the procedure, immediately after securing the endotracheal tube 
Opioid requirement during procedure  End of the procedure 
Incidence of adverse events  24 hours postoperatively 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="102" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   01/10/2024 
Date of Study Completion (India) 04/03/2026 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary
Modification(s)  

Background

Awake fibreoptic intubation (AFOI) is the gold standard for securing the airway in patients with anticipated difficult airways because it preserves spontaneous ventilation and airway reflexes. However, successful AFOI depends on achieving an optimal balance between adequate sedation, analgesia, patient cooperation, and hemodynamic stability without causing respiratory depression. Dexmedetomidine is widely used because it provides cooperative sedation but is associated with bradycardia and hypotension. A combination of subanaesthetic intravenous ketamine and lignocaine may provide effective sedation, analgesia, and airway reflex suppression while maintaining cardiovascular stability. This study compared the efficacy and safety of intravenous ketamine–lignocaine with dexmedetomidine for AFOI.

Objectives

Primary objective:

  • To compare the effectiveness of subanaesthetic intravenous ketamine plus lignocaine versus intravenous dexmedetomidine in achieving optimal intubating conditions during awake fibreoptic intubation.

Secondary objectives:

  • To compare hemodynamic parameters.
  • To evaluate opioid (fentanyl) requirement.
  • To compare adverse events associated with both regimens.

Methodology

This was a prospective, randomized, triple-blinded clinical trial conducted over 18 months at AIIMS Raipur. One hundred ASA I–II patients aged 18–60 years with anticipated difficult airway (El-Ganzouri score 4–12) undergoing elective surgery were randomized into two equal groups (n=50 each).

  • Group KL: Ketamine 0.3 mg/kg IV bolus + infusion 0.3 mg/kg/h with lignocaine 1.5 mg/kg IV bolus + infusion 1.5 mg/kg/h.
  • Group D: Dexmedetomidine 1 µg/kg over 10 minutes followed by infusion 0.2–0.7 µg/kg/h.

Primary outcomes included Modified Observer’s Assessment of Alertness/Sedation (MOAA/S) score, endoscopy time, intubation time, endoscopist satisfaction, patient discomfort, and postoperative recall. Secondary outcomes included heart rate, mean arterial pressure, oxygen saturation, opioid requirement, and adverse events.

Results

Baseline characteristics including age, gender, BMI, ASA status, and El-Ganzouri score were comparable between groups (all p > 0.05).

Compared with dexmedetomidine, the ketamine–lignocaine group demonstrated:

  • Deeper sedation: MOAA/S score 2.82 ± 0.72 vs 3.12 ± 0.72 (p = 0.040).
  • Significantly shorter intubation time: 21.22 ± 9.06 s vs 34.96 ± 10.80 s (p < 0.001).
  • Lower patient discomfort: 1.84 ± 0.79 vs 2.26 ± 0.96 (p = 0.027).
  • Comparable endoscopy time (2.55 ± 1.24 vs 2.96 ± 1.43 min; p = 0.107) and endoscopist satisfaction (p = 0.119).

Postoperative recall was significantly lower in the ketamine–lignocaine group during:

  • Topical anaesthesia (12% vs 38%; p = 0.003).
  • Intubation (36% vs 78%; p < 0.001).

There was no significant difference in recall of pre-anaesthetic preparation (p = 0.099) or endoscopy (p = 0.202). Adverse events were comparable between groups (16% vs 12%; p = 0.564). Hemodynamically, dexmedetomidine produced lower heart rate and mean arterial pressure, whereas ketamine–lignocaine caused transient increases during intubation that remained clinically acceptable.

Discussion

The study demonstrated that ketamine combined with lignocaine provided superior intubating conditions compared with dexmedetomidine. Patients experienced deeper yet cooperative sedation, faster intubation, less discomfort, lower recall during airway manipulation, and reduced opioid requirement while maintaining adequate oxygenation and acceptable hemodynamic stability. Although dexmedetomidine offered stable sedation, its tendency to produce bradycardia and hypotension may limit its use in selected patients. The findings support the complementary pharmacological effects of ketamine and lignocaine in improving airway conditions without increasing complications.

Conclusion

Subanaesthetic intravenous ketamine combined with lignocaine is an effective and safe alternative to dexmedetomidine for awake fibreoptic intubation in anticipated difficult airways. It provides significantly better intubating conditions, shorter intubation time, reduced patient discomfort and recall, and lower opioid requirement while maintaining clinically acceptable hemodynamic stability and a safety profile comparable to dexmedetomidine.


 
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