Efficacy of Esmolol Versus Magnesium Sulphate on Quality of Recovery in Patients Undergoing Laparoscopic Cholecystectomy: Randomized Controlled Study

NCT05850832 | Completed Phase 2 DMC

• 1 other identifier: 0305810
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

sixty patients, of both sexes, of ASA I or II planned for ambulatory laparoscopic cholecystectomy under general anaesthesia were engaged into 2 groups. Esmolol group were given 1 mg/kg loading dose followed by 30 μg/kg/min throughout the surgery, whereas magnesium sulphate (MgSo4) group were given loading dose 40 mg/kg over 15 mins then maintenance dose 15 mg/kg/h till end of surgery. General anaesthesia was standardized and postoperative analgesia included fentanyl. Variables denoting immediate recovery from anaesthesia, pain score and time of stay in PACU were recorded. White-Song score ≥ 12 along with pain score \< 4 were the cut off levels for patients' discharge from PACU.

Conditions

Esmolol Adverse Reaction

Keywords

cholecystectomy; recovery profile; opioid sparing

Outcome Measures

Primary Outcomes (1)

• times needed for spontaneous eye opening

  time passed from end of procedure until the patient open his eyes

  immediately postoperative

Secondary Outcomes (1)

• total amount of intraoperative fentanyl consumption

  immediately postoperative

Study Arms (2)

Group E

ACTIVE COMPARATOR

Esmolol group: patients received loading dose 1 mg/kg followed by maintenance dose of 30 μg/kg/min throughout the surgery

Drug: Esmolol

Group M

ACTIVE COMPARATOR

Magnesium sulphate group: patients received loading dose 40 mg/kg over a period of 15 mins and maintenance 15 mg/kg/h throughout the surgery.

Drug: Magnesium sulfate

Interventions

Esmolol DRUG

loading dose 1 mg/kg followed by maintenance dose of 30 μg/kg/min throughout the surgery.

Group E

Magnesium sulfate DRUG

loading dose 40 mg/kg over a period of 15 mins and maintenance 15 mg/kg/h throughout the surgery.

Group M

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients aged 20-65 years of both sexes

You may not qualify if:

• patients on chronic use or known allergic to the study drugs
• body mass index \>35 kg/m2,
• significant organ dysfunction, cardiac dysrhythmias, neuromuscular diseases
• liver or renal disease,
• known asthma or reactive airway diseases.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria University Faculty of Medicin

Alexandria, 21615, Egypt

Location

MeSH Terms

Interventions

esmolol; Magnesium Sulfate

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 60 patients aged 20-65 years of both sexes, of American society of Anesthesiologists (ASA) physical status I and II planned for ambulatory laparoscopic cholecystectomy under general anaesthesia were engaged to this study. * Group (E): (Esmolol group) received loading dose 1 mg/kg followed by maintenance dose of 30 μg/kg/min throughout the surgery. * Group (M): (Magnesium sulphate group) received loading dose 40 mg/kg over a period of 15 mins and maintenance 15 mg/kg/h throughout the surgery.

Study Record Dates

• First Submitted: April 29, 2023
• First Posted: May 9, 2023
• Study Start: October 5, 2022
• Primary Completion: January 5, 2023
• Study Completion: April 10, 2023
• Last Updated: May 9, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)