NCT07180810

Brief Summary

A randomised control trial evaluating the effect of low dose dexmedetomidine infusion on post anesthesia discharge time in patients of day case breast cancer surgery compared with placebo infusion. The primary outcome was to compare the frequency of early discharge in each group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
82

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2023

Typical duration for not_applicable

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

September 5, 2023

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 20, 2025

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 18, 2025

Completed
Last Updated

September 23, 2025

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

September 12, 2025

Last Update Submit

September 17, 2025

Conditions

Keywords

Breast cancer surgery, Dexmedetomidine, Post anesthesia discharge time

Outcome Measures

Primary Outcomes (1)

  • Frequency of early discharge

    post anesthesia discharge time within 2 hours

    120 minutes

Study Arms (2)

Group A, receiving low dose dexmedetomidine infusion

EXPERIMENTAL

Group A, receiving low dose dexmedetomidine infusion at 0.6mcg/kg/hour rate

Drug: Dexmedetomidine infusion low dose

Group B, receiving normal saline infusion as placebo

PLACEBO COMPARATOR

normal saline being used as placebo at rate 0.6mch/kg/hour rate

Drug: Group B receiving normal saline

Interventions

low dose dexmedetomidine infusion at rate 0.6mcg/kg/hour rate .

Group A, receiving low dose dexmedetomidine infusion

Normal saline infusion at rate 0.6mcg/kr/hour rate

Group B, receiving normal saline infusion as placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age 18-60 yrs, ASA 1 and 2, elective breast cancer surgery

You may not qualify if:

  • BMI greater than 35, CKD stage 3 or greater, known drug allergy to study drug, bradycardia, history of PONV, patients on antiepileptics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Shaukat Khanum Memorial Cancer Hospital and Research Centre

Lahore, Pubjab, 54782, Pakistan

Location

Related Links

Study Officials

  • Almas nil Iqbal, FRCA

    Shaukat Khanum Memorial Cancer Hospital and Research Centre, Lahore

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
Double blinded study, all participants, and the care provider providing anesthesia to the participants were blinded
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Group A being administered low dose intravenous dexmedetomidine infusion vs Group B being admissions IV normal saline infusion at rate 0.6mcg/kg/hour rate
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2025

First Posted

September 18, 2025

Study Start

September 5, 2023

Primary Completion

August 20, 2025

Study Completion

August 20, 2025

Last Updated

September 23, 2025

Record last verified: 2023-08

Data Sharing

IPD Sharing
Will not share

undecided

Locations