Comparing nebulised lignocaine and intravenous dexmedetomidine in response of airway instrumentation.

Phase 3

Not yet recruiting

• Conditions: Calculus of bile duct with cholecystitis,

• Registration Number: CTRI/2020/07/026918
• Lead Sponsor: IMS AND SUM HOSPITAL

Brief Summary

**To observe and compare the effectiveness of preoperativeadministration of intravenous Dexmedetomidine versus Nebulization of 4%solution of Lignocaine versus combination of both in attenuating thehemodynamic pressor response to laryngoscopy and endotracheal intubationpatients undergoing laparoscopic Cholecystectomy** **Surgery.**

To find out the change in heart rate and meanblood pressure( in terms of 20% rise from baseline values) in three groups ofpatients undergoing laparoscopic Cholecystectomy, namely :

1.  Group“D†(intravenous Dexmedetomidine group),          2. Group“L†(nebulized 4% Lignocaine) and        3. Group“DL†(combination of Both)

 Group “D†will receive intravenous Dexmedetomidine 1mcg/kginfusion over 10 minutes before induction of anesthesia and receive NormalSaline 0.9% in Nebulization (assuming Normal Saline to be 4% Lignocaine) in thepreoperative room.

Group “L†will receive Nebulization with 3mg/kg solution of 4%Lignocaine via a face mask and cirrus nebulizer with Oxygen at the rate of 8L/min in the preoperative room and Normal Saline infusion in infusion syringeover 10min before induction(assuming it to beintravenous Dexmedetomidine infusion) in the operative room .

Group “DL†group will receive Nebulization with 3mg/kg solution of4% Lignocaine via a face mask and cirrus nebulizer with Oxygen at the rate of 8L/min in the preoperative room and intravenous Dexmedetomidine 1mcg/kg infusionover 10 minutes in the operative room.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-01-08
• Last Update Posted: 2020-07-29

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

• Patients belonging to ASA Grade I.
• II status posted for laparoscopic Cholecystectomy Surgery,Securing airway within 30 seconds,Airway examination: Mallampatti Grade- 1,2; Neck Extension > 6.5cm, Mouth Opening> 3 fingers, Age group: 18 to 50 years.

Exclusion Criteria

• 1.The patients who did not give consent 2.The American society of anesthesiology (ASA) physical status > II 3.Weight: <40kg or >70kg 4.Anticipated difficult airway (Mallampati Grade-3,4; Cormack-Lehane Grade-3,4), short neck 5.Patients with history of any medication or substance abuse 6.Age: <18years or >50 years 7.BMI more than 30 8.Height: <150cm or >180cm 9.Base line Heart rate: ≤60 bpm or ≥90bpm.
• 10.Baseline Blood pressure: ≤90/50(65) mmhg or ≥140/85(105) mmhg.
• 11.Smokers, history of any respiratory disease, gastro esophageal reflux disease.
• 12.Patients taking antihypertensive or any alpha-2 agonist 13.No postural hypotension.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To find out the change in heart rate and mean blood pressure( in terms of 20% rise from baseline values) in three groups of patients undergoing laparoscopic Cholecystectomy, namely :	Heart rate, Systolic Blood Pressure, Diastolic Blood Pressure and Mean Arterial Pressure measured at Baseline, Before Nebulization ,After Nebulizaton, Before Infusion, Before Laryngoscopy and After Intubation at 1, 3, 5, 7, 10 minutes.
2.Group “L†(nebulized 4% Lignocaine) and	Heart rate, Systolic Blood Pressure, Diastolic Blood Pressure and Mean Arterial Pressure measured at Baseline, Before Nebulization ,After Nebulizaton, Before Infusion, Before Laryngoscopy and After Intubation at 1, 3, 5, 7, 10 minutes.
3.Group “DL†(combination of Both)	Heart rate, Systolic Blood Pressure, Diastolic Blood Pressure and Mean Arterial Pressure measured at Baseline, Before Nebulization ,After Nebulizaton, Before Infusion, Before Laryngoscopy and After Intubation at 1, 3, 5, 7, 10 minutes.
1.Group “D†(intravenous Dexmedetomidine group),	Heart rate, Systolic Blood Pressure, Diastolic Blood Pressure and Mean Arterial Pressure measured at Baseline, Before Nebulization ,After Nebulizaton, Before Infusion, Before Laryngoscopy and After Intubation at 1, 3, 5, 7, 10 minutes.

Secondary Outcome Measures

Name	Time	Method
not applicable	0

Trial Locations

Locations (1)

IMS AND SUM HOSPITAL; 🇮🇳 Khordha, ORISSA, India

IMS AND SUM HOSPITAL

🇮🇳Khordha, ORISSA, India

ZEESHAN HAIDER WARSI

Principal investigator

7542097805

zeeshanamu89@gmail.com