Attenuate the Stress Response in Laparoscopic Cholecystectomy

ConditionLaparoscopic Cholecystectomy Surgery

Trial statusNot yet recruiting

Trial phasePhase 4

Trial typeInterventional

Biological sexAll

Age18-65

SponsorAssiut University

About this trial

Aims of this study are to compare the effectiveness of dexmedetomidine versus fentanyl-midazolam in attenuating hemodynamic stress response during laparoscopic cholecystectomy (mainly HR). And to assess the recovery profile, the pain and opioid requirements, the sedation profile, and any adverse events during the first 24 hrs postoperatively

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-65 years.

Both sexes.

American Society of Anesthesiology (ASA) physical status I - II.

Disqualifiers

Known allergy to study drugs.

Uncontrolled, non-correctable comorbidities (hepatic, renal or cardiac such as hypertension & Arrhythmia ).

History of psychiatric illness or substance abuse.

Pregnancy or lactation

Trial design

Design model

Parallel

Treatments tested in this trial

Dexmedetomidine
Drug
investigator will give Loading dose 1 mcg/kg IV over 10 min, followed by infusion 0.5 mcg/kg/h until pneumoperitoneum established
Fentanyl- midazolam
Drug
Investigator will inject Fentanyl 2 mcg/kg IV + Midazolam 0.05 mg/kg IV before induction.

Treatment groups

50 Participants

are divided into 2 treatment groups

Group A: Dexmedetomidine GroupExperimental treatment 1 intervention

Group B: Fentanyl-Midazolam GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Hemodynamics

Hemodynamics mainly HR

Time frame

During procedure

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Assiut University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: