| 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 |
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Scientific Title of Study
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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 |
|
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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 |
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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 |
|
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Source of Monetary or Material Support
|
| Department of Anesthesiology, All India Institute of Medical Sciences, Raipur |
|
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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] |
|
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Details of Secondary Sponsor
|
|
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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 |
|
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Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTE ETHICS COMMITTEE |
Approved |
|
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Regulatory Clearance Status from DCGI
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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, |
|
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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 |
|
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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 |
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Method of Generating Random Sequence
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Computer generated randomization |
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Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
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Blinding/Masking
|
Participant, Investigator and Outcome Assessor Blinded |
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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 |
|
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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
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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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