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

NCT ID: NCT05937282

Last Updated: 2023-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2023-10-30

Brief Summary

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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.

Detailed Description

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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

Conditions

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Hemodynamic Responses Laparoscopic Cholecystectomy Dexmedetomidine Lidocaine Propofol

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Control group

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

Group Type PLACEBO_COMPARATOR

normal saline

Intervention Type DRUG

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

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.

Group Type ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type DRUG

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.

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

Group Type ACTIVE_COMPARATOR

Propofol

Intervention Type DRUG

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.

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.

Group Type ACTIVE_COMPARATOR

Lidocain

Intervention Type DRUG

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.

Interventions

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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.

Intervention Type 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.

Intervention Type 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.

Intervention Type DRUG

normal saline

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Menoufia University

OTHER

Sponsor Role lead

Responsible Party

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Ahmed Mohammed Nasar

Specialist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Menoufia University

Shibīn al Kawm, Menoufia, Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Ahmed M Nassar, MSc

Role: CONTACT

+20 122 682 5175

Facility Contacts

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Ahmed M Nassar

Role: primary

+20 122 682 5175

Other Identifiers

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2/2020ANET27

Identifier Type: -

Identifier Source: org_study_id

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