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

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

Study Overview

• Status: Unknown
• Conditions: Laparoscopic Cholecystectomy
• Intervention / Treatment: Drug: dexmedetomidine; Drug: fentanyl; Drug: lidocaine

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 Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 75520
      • Recruiting
      • DUHS, Civil hospital Karachi (CHK)
      • Contact: Phone Number: 0333351560; Email: dr.sanaurooj@yahoo.com
      • Principal Investigator: Sana Urooj, FCPS
      • Sub-Investigator: Hanya Jawed, FCPS-res

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Sana Urooj
• Collaborators: Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 30, 2019
• Primary Completion (Anticipated): February 29, 2020
• Study Completion (Anticipated): February 29, 2020

Study Registration Dates

• First Submitted: October 14, 2019
• First Submitted That Met QC Criteria: October 22, 2019
• First Posted (Actual): October 24, 2019

Study Record Updates

• Last Update Posted (Actual): February 7, 2020
• Last Update Submitted That Met QC Criteria: February 6, 2020
• Last Verified: February 1, 2020

More Information

Terms related to this study

• Keywords: Fentanyl; Dexmedetomidine; Laryngoscopy; Laparoscopic Cholecystectomy; Lignocaine; Hemodynamic Response
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Non-Narcotic; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Analgesics, Opioid; Narcotics; Membrane Transport Modulators; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Fentanyl; Dexmedetomidine; Lidocaine
• Other Study ID Numbers: 3

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No