NCT06065956

Brief Summary

Comparing hemodynamic changes with morphine versus esmolol as an adjuvant agent during induction of Anaesthesia

Trial Health

87
On Track

Trial Health Score

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

Enrollment
110

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Aug 2022

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

August 28, 2022

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 15, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 29, 2023

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 4, 2023

Completed
Last Updated

October 4, 2023

Status Verified

October 1, 2023

Enrollment Period

10 months

First QC Date

August 29, 2023

Last Update Submit

October 1, 2023

Conditions

Intubation Complication

Outcome Measures

Primary Outcomes (2)

  • Blood pressure

    Change in blood pressure between baseline value and post Intubation value will be measured in millimeter of mercury (mmHg).

    06 months

  • Pulse rate

    Change in pulse rate between baseline value and post intubation value will be measured per minute.

    06 months

Study Arms (2)

Morphine group

EXPERIMENTAL

Half of participants will be comprising of morphine group

Drug: Intravenous morphine

Esmolol group

EXPERIMENTAL

Half of participants will be comprising of esmolol group

Drug: Intravenous morphine

Interventions

Intravenous morphineDRUG

Morphine group(an opioid), participants were given intravenous morphine(an opioid) at induction of General Anaesthesia before laryngoscopy and intubation. The other group,Esmolol group(cardioselective beta blocker), participants were given intravenous esmolol(cardioselective beta blocker) during induction of General Anesthesia before laryngoscopy and intubation.

Also known as: Intravenous esmolol
Esmolol groupMorphine group

Eligibility Criteria

Age25 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • ASA 2 patients presenting for elective surgery.

You may not qualify if:

  • Patients having major cardiac disease.
  • Metastatic disease.
  • Pregnant females.
  • Those unwilling to be part of study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PNS Shifa Hospital

Karachi, Sindh, 46000, Pakistan

Location

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
FCPS 2 Registrar in Anaesthesiology

Study Record Dates

First Submitted

August 29, 2023

First Posted

October 4, 2023

Study Start

August 28, 2022

Primary Completion

June 15, 2023

Study Completion

July 15, 2023

Last Updated

October 4, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)