Hemodynamic Responses of Dexmedetomidine, Lidocaine or Propofol Infusions During Laparoscopic Cholecystectomy

Sponsor

Menoufia University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05937282

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

20.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hemodynamic Responses Laparoscopic Cholecystectomy Dexmedetomidine Lidocaine Propofol	Drug: Dexmedetomidine Drug: Propofol Drug: Lidocain Drug: normal saline	Phase 4

Detailed Description

Many drug infusions have been used to control hemodynamic responses to laparoscopic surgeries like propofol, fentanyl, esmolol with varying degrees of success.

Dexmedetomidine has sedative and analgesic properties seems to be appropriate enough to control the sympathetic response as well as provide a stable hemodynamics

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Comparative Study Between the Hemodynamic Responses of Dexmedetomidine, Lidocaine or Propofol Infusions During Laparoscopic Cholecystectomy

Actual Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Oct 30, 2023

Anticipated Study Completion Date :

Oct 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Placebo Comparator: Control group Patients will receive infusion of 25 ml normal saline in 50 ml syringe pump.	Drug: normal saline Patients will receive infusion of 25 ml normal saline in 50ml syringe pump (control group).
Active Comparator: Dexmedetomidine group 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 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.
Active Comparator: Propofol 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 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.
Active Comparator: Lidocaine 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 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.

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

Intraoperative rescue drugs [Intraoperatively]
Patients that will need rescue drugs (fentanyl) will be recorded with the total dose used.
Post extubation sedation [24 hour postoperatively]
Post extubation sedation assessment will be done in each group using Ramsey's sedation score. Anxious, agitated or restless = (1) Cooperative, oriented and tranquil = (2) Responsive to command only = (3) Brisk response to light glabellar tap or loud auditory stimulus = (4) Sluggish response to light glabellar tap or loud auditory stimulus = (5) No response = (6)

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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

Exclusion Criteria:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Menoufia University	Shibīn Al Kawm	Menoufia	Egypt

Sponsors and Collaborators

Menoufia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ahmed Mohammed Nasar, Specialist, Menoufia University

ClinicalTrials.gov Identifier:

NCT05937282

Other Study ID Numbers:

2/2020ANET27

First Posted:

Jul 10, 2023

Last Update Posted:

Jul 11, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Yes

Additional relevant MeSH terms:

Lidocaine

Dexmedetomidine

Propofol

Study Results

No Results Posted as of Jul 11, 2023