NCT05909215

Brief Summary

Two doses of Dexmedetomidine (0.5 µ/kg and 0.75 µ/kg) will be used to attenuate the stress response to laryngoscopy in American Society of Anesthesiology, physical class I patients which will be compared with the placebo-controlled group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
105

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Aug 2021

Shorter than P25 for phase_4

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 23, 2021

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 13, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 13, 2021

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2023

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 18, 2023

Completed
Last Updated

June 18, 2023

Status Verified

June 1, 2023

Enrollment Period

4 months

First QC Date

February 7, 2023

Last Update Submit

June 9, 2023

Conditions

Hemodynamic InstabilityTracheal IntubationDexmedetomidine

Keywords

Systolic Blood PressureDiastolic Blood PressureHeart RateMean Arterial PressurePrecedexTracheal IntubationLaryngoscopySedation

Outcome Measures

Primary Outcomes (1)

  • Hemodynamic Response

    Mean change in the heart rate, systolic blood pressure, diastolic blood pressure, and mean arterial pressure will be assessed.

    0 to 10 minutes after endotracheal intubation

Secondary Outcomes (1)

  • Adverse events

    0 to 30 minutes from the start of infusion to 10 minutes after endotracheal intubation)

Study Arms (3)

Dexmedetomidine 0.5

ACTIVE COMPARATOR

Dexmedetomidine 0.5 μ/kg diluted in 20 mL normal saline through a syringe pump over 10 minutes followed by general anesthesia.

Drug: Normal salineDrug: Dexmedetomidine 0.5 microgram/kg

Dexmedetomidine 0.75

ACTIVE COMPARATOR

Dexmedetomidine 0.75 μ/kg diluted in 20 mL normal saline through a syringe pump over 10 minutes followed by general anesthesia.

Drug: Normal salineDrug: Dexmedetomidine 0.75 microgram/kg

Placebo

PLACEBO COMPARATOR

20 mL of normal saline as an infusion through a syringe pump over 10 minutes followed by induction of general anesthesia.

Drug: Normal saline

Interventions

Normal salineDRUG

Normal saline 20mL will be given intravenously through a syringe pump over 10 minutes

Also known as: Placebo group
Dexmedetomidine 0.5Dexmedetomidine 0.75Placebo
Dexmedetomidine 0.5 microgram/kgDRUG

Dexmedetomidine 0.5 microgram/kg diluted in 20mL of normal saline will be given intravenously through a syringe pump over 10 minutes

Dexmedetomidine 0.5
Dexmedetomidine 0.75 microgram/kgDRUG

Dexmedetomidine 0.75 microgram/kg diluted in 20mL of normal saline will be given intravenously through a syringe pump over 10 minutes

Dexmedetomidine 0.75

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Age between 18 to 55 years
  • ASA I or II patients undergoing surgery under general anaesthesia with endotracheal intubation.
  • Patients with Mallampati class I or II.

You may not qualify if:

  • ASA III \& IV patients
  • Anticipated or unanticipated difficult intubations which requires more than 15 seconds or more than one attempt.
  • Patients with Mallampati class III, IV or with loose teeth.
  • Patients with inotropes infusion.
  • Patients with known allergy to any anaesthetic agents
  • Patients with a heart rate of 60 beats/min or less
  • Patients with known hypertension, incidental finding of hypertension while on operating table, diabetes, ischemic heart disease or peripheral vascular disease.
  • Pregnant and lactating mothers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Syed Muhammad Abbas

Karachi, Sindh, 74200, Pakistan

Location

MeSH Terms

Interventions

Saline Solution

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Officials

  • Syed M Abbas

    Associate Professor Dept of Anaesthesia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Department of Anaesthesia

Study Record Dates

First Submitted

February 7, 2023

First Posted

June 18, 2023

Study Start

August 23, 2021

Primary Completion

December 13, 2021

Study Completion

December 13, 2021

Last Updated

June 18, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

PA(1)