Comparison Of Dexmedetomidine, Fentanyl And Lignocaine In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy

Not Applicable

• Conditions: Laparoscopic Cholecystectomy
• Interventions: Drug: fentanyl; Drug: lidocaine; Drug: dexmedetomidine

• Registration Number: NCT04138472
• Lead Sponsor: Sana Urooj

Brief Summary

Comparison Of Dexmedetomidine, Fentanyl And Lignocaine In Attenuation Of Hemodynamic Response To Direct Laryngoscopy And Intubation In Patient Undergoing Laparoscopic Cholecystectomy

Detailed Description

Direct laryngoscopy and intubation are painful stimulus that activates sympathoadrenal discharge which results in intense cardiovascular reflex i.e. tachycardia and hypertension. In this study we will compare effects of intravenous dexmedetomidine, fentanyl and lidocaine for attenuation of these reflexes in patient undergoing laproscopic cholecystectomy. how these agents will effect hemodynamic response during pneumoperitoneum. Tertiary objective will be to observe sedation, perioperative complications and recovery in these patients.

Study Timeline

• Study First Submitted: 2019-10-14
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-24
• Study Start: 2019-10-30
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-06
• Last Update Posted: 2020-02-07
• Primary Completion: 2020-02-29
• Study Completion: 2020-02-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• ASA-I and ll patients
• Male and female patient of age 20-70 years.
• Undergoing Elective surgery
• Intubation by skilled anesthetist of at least 2 years' experience
• Intubation not more than 45 seconds

Exclusion Criteria

• Patients with uncontrolled DM, HTN, IHD, endocrine or autonomic dysfunction
• Pregnant and lactating females
• Short thick neck with anticipated difficult intubation
• Any sort of obstructive restrictive or reactive airway disease
• Patient allergic to any of the study medications.
• Obese patients, Narcotic addicts

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fentanyl	fentanyl	Group B receives intravenous fentanyl at 2mcg/kg in 100ml saline over 10 minutes in induction room.
Lidocaine	lidocaine	Group C patients receives intravenous lidocaine 1.5mg/kg in 100ml saline over 10 minutes in induction room.
Dexmedetomidine	dexmedetomidine	Group A patients receive intravenous dexmedetomidine 0.06mg/kg in 100ml normal saline 0.9% over 10minutes.

Primary Outcome Measures

Name	Time	Method
Heart rate	at induction	Hemodynamic responses (average heart rate beats a minute)
systolic blood pressure	at induction	hermodynamic response (Top number will be assessed of blood pressure)
mean atrial pressure	at induction	Hemodynamic responses (average blood pressure in an individual during a single cardiac cycle)
Oxygen saturation (SpO2)	at induction	Hemodynamic responses) (arterial oxy-hemoglobin saturation is measured non-invasively by a finger pulse oximeter or handheld pulse oximeter,
Diastolic blood pressure	at induction	hermodynamic response (bottom number will be assessed of blood pressure)

Secondary Outcome Measures

Name	Time	Method
Sedation assessment	at 10 minutes post operative	Ramsey score use for sedation, it consist of 1-6 where 6 indicates worst(no response) and 6 indicates good response
Recovery assessment	at 10 minutes post operatively	Aldret score use for recovery assessment, it consist of 0-10 point where 0 indicates worst(no response) and 10 indicates good response
Complications	1 week Post-operative(Operation -discharge)	Cough, Laryngospasm, Bradycardia, Regugitation, PONV, Hypertention, Hypotension

Trial Locations

Locations (1)

DUHS, Civil hospital Karachi (CHK); 🇵🇰 Karachi, Sindh, Pakistan