NCT05937282

Brief Summary

This study will be carried out to compare the efficacy of dexmedetomidine, propofol or lidocaine infusions in attenuation of hemodynamic responses to pneumoperitoneum during adult laparoscopic cholecystectomy using electrical cardiometry.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jul 2023

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

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

First Submitted

Initial submission to the registry

June 18, 2023

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

July 10, 2023

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2023

Completed
Last Updated

July 11, 2023

Status Verified

July 1, 2023

Enrollment Period

4 months

First QC Date

June 18, 2023

Last Update Submit

July 9, 2023

Conditions

Hemodynamic ResponsesLaparoscopic CholecystectomyDexmedetomidineLidocainePropofol

Outcome Measures

Primary Outcomes (1)

  • Noninvasive mean blood pressure

    mean blood pressure will be noted by a standard automated multi channel monitor will be connected to each patient

    Intraoperatively

Secondary Outcomes (2)

  • Intraoperative rescue drugs

    Intraoperatively

  • Post extubation sedation

    24 hour postoperatively

Study Arms (4)

Control group

PLACEBO COMPARATOR

Patients will receive infusion of 25 ml normal saline in 50 ml syringe pump.

Drug: normal saline

Dexmedetomidine group

ACTIVE COMPARATOR

Patients will receive infusion of dexmedetomidine in the dose of 0.4 μg/kg/hr. One ml dexmedetomidine (100 μg/ml) will be diluted with 24 ml normal saline in 50 ml syringe pump to achieve dilution of 4 μg/ml.

Drug: Dexmedetomidine

Propofol

ACTIVE COMPARATOR

Patients will receive propofol infusion in the dose of 3 mg/kg/hr. (12) 25 ml propofol 1% (10 mg /ml) in 50 ml syringe pump

Drug: Propofol

Lidocaine

ACTIVE COMPARATOR

Patients will receive lidocaine infusion in the dose of 2 mg /kg/hr. (15) 25 ml lidocaine 1% (10 mg/ml) in 50 ml syringe pump.

Drug: Lidocain

Interventions

DexmedetomidineDRUG

Patients will receive infusion of dexmedetomidine in the dose of 0.4 μg/kg/hr. One ml dexmedetomidine (100 μg/ml) will be diluted with 24 ml normal saline in 50 ml syringe pump to achieve dilution of 4 μg/ml.

Dexmedetomidine group
PropofolDRUG

Patients will receive propofol infusion in the dose of 3 mg/kg/hr. 25 ml propofol 1% (10 mg /ml) in 50 ml syringe pump.

Propofol
LidocainDRUG

Patients will receive lidocaine infusion in the dose of 2 mg /kg/hr.25 ml lidocaine 1% (10 mg/ml) in 50 ml syringe pump.

Lidocaine
normal salineDRUG

Patients will receive infusion of 25 ml normal saline in 50ml syringe pump (control group).

Control group

Eligibility Criteria

Age20 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • American Society of Anesthesiologists I patients.
  • Patients between the ages of ≥ 20 and ≤ 60 years of both sexes.

You may not qualify if:

  • Hypersensitivity to dexmedetomidine, propofol or lidocaine.
  • Diabetic patients (Hemoglobin A1C ≥ 7).
  • Hypertensive patients (Blood presssure ≥ 140/90 mmHg) or patients on medications that affect hemodynamics as clonidine, methyldopa, β blockers and calcium channel blockers.
  • Impaired liver function (serum albumin ≤ 3.5 g/dl, International normalized ratio≥ 1.3, total bilirubin \>1mg/dl).
  • Impaired renal function (serum creatinine \>1.2 mg/dl, blood urea \>20mg/dl).
  • Morbidly obese patients with body mass index ≥ 40.
  • Patients with acute cholecystitis or active infection.
  • Patients taking medications that may impair cognition.
  • History of seizures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Menoufia University

Shibīn al Kawm, Menoufia, Egypt

RECRUITING

MeSH Terms

Interventions

DexmedetomidinePropofolSaline Solution

Intervention Hierarchy (Ancestors)

ImidazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Central Study Contacts

Ahmed M Nassar, MSc

CONTACT

+20 122 682 5175ahmednasar35@gmail.com

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
Specialist

Study Record Dates

First Submitted

June 18, 2023

First Posted

July 10, 2023

Study Start

July 1, 2023

Primary Completion

October 30, 2023

Study Completion

October 30, 2023

Last Updated

July 11, 2023

Record last verified: 2023-07

Data Sharing

IPD Sharing
Will share

The data will be available upon reasonable request from the corresponding author from one year after study completion

Time Frame
from one year after study completion
Access Criteria
The data will be available upon reasonable request from the corresponding author

Locations

EG(1)