NCT07385040

Brief Summary

Hemodymanic stress response to direct laryngoscopy and endotracheal intubation is a known phenomenon that occur in almost every patient undergoing general anesthesia before surgical procedure. This response leads to sudden rise in heart rate and blood pressure which may cause serious complications in compromised patients having cardiovascular diseases. There are certain drugs which are used to blunt this response and to prevent the life threatening complications. Intravenous Lignocain is commonly used drug to blunt the laryngoscopic response in our setup. Intravenous Dexmedetomidine is a newer and rarely used drug to prevent stress response to direct laryngoscopy and endotracheal intubation. This study aims to compare the efficacy of both the drugs to provide better control of complications like Arrythmias, stroke and cardiovascular instability.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
62

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Apr 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 13, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

December 7, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 3, 2026

Completed
Last Updated

February 3, 2026

Status Verified

January 1, 2026

Enrollment Period

9 months

First QC Date

December 7, 2025

Last Update Submit

January 29, 2026

Conditions

Keywords

Direct laryngoscopyHemodynamic stress responseLignocaineDexmedetomidine

Outcome Measures

Primary Outcomes (1)

  • Hemodynamic stress response

    Rise in Heart rate and mean arterial pressure

    1 minute and 3 minute after endotracheal intubation

Study Arms (2)

Group L

ACTIVE COMPARATOR

Group L received IV Lignocain 1.5mg/kg before induction.

Drug: Intravenous Lignocain

Group D

ACTIVE COMPARATOR

Group D received IV Dexmedetomidine infusion 10mics/ kg over 10min before induction

Drug: Intravenous Dexmedetomidine infusion

Interventions

Dexmedetomidine infusion with dose of 10mics/kg given 10min before induction

Group D

Intravenous ligoncain 1.5mg/kg given 90sec before induction.

Group L

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients undergoing general anesthesia for any elective surgery Having ASA 1 or 2 Having mallapatti 1 or 2 Having BMI in between 18-30 kg/m2

You may not qualify if:

  • Lack of consent Anticipated difficult airway Pregnancy Sensitivity to either drug

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Maryam

Karachi, Sindh, 7523, Pakistan

Location

Related Publications (1)

  • Mahiswar AP, Dubey PK, Ranjan A. Comparison between dexmedetomidine and fentanyl bolus in attenuating the stress response to laryngoscopy and tracheal intubation: a randomized double-blind trial. Braz J Anesthesiol. 2022 Jan-Feb;72(1):103-109. doi: 10.1016/j.bjane.2021.02.060. Epub 2021 May 14. PMID: 34000325; PMCID: PMC9373229.

    BACKGROUND

Related Links

MeSH Terms

Conditions

TachycardiaHypertension

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesCardiac Conduction System DiseasePathologic ProcessesPathological Conditions, Signs and SymptomsVascular Diseases

Study Officials

  • Maryam Maryam

    Shaheed Mohtarma Benazir Bhutto Institue of Trauma

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Single blinded, randomised control trial
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Anesthesiologist

Study Record Dates

First Submitted

December 7, 2025

First Posted

February 3, 2026

Study Start

April 13, 2023

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

February 3, 2026

Record last verified: 2026-01

Locations