Effects Of Additional MgSO4 30 Mg/KgBW Intravenous and Ketorolac

NCT ID: NCT05609955

Last Updated: 2022-11-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2022-11-01

Brief Summary

This study aims to compare two groups of post-orthopedic patients who received a standard regimen, namely ketorolac 30mg, to the second group, which was given the standard regimen and adjuvant magnesium sulfate 30mg/kgBW 1 hour preoperatively. If it is proven useful, it is hoped that pain will be more controlled, reduce pain complications, reduce treatment costs, and reduce the duration of hospital stays.

Detailed Description

The study design used was a randomized controlled trial (RCT) with double blinds. Double blind because neither the patient, the lead investigator, nor the investigator on record knew the drug or placebo that was administered. Research subjects were selected consecutively in patients who will undergo lower extremity surgery at the Cipto Mangunkusumo National Central General Hospital. Forty-eight research subjects will be divided into two groups, namely the group given Intravenous Magnesium Sulfate 30 mg/kgBW and the group given a placebo. Research subjects were randomized by type of surgery using randomization software by research assistants. The results of randomization were not known to the patient, the principal investigator, or the researcher taking notes.

This study aims to determine the effect of adding 30 mg/kg body weight of intravenous MgSO4 to 30 mg of ketorolac on the degree of pain and the need for opioids after lower extremity surgery.

Conditions

Anesthesia; Pain, Postoperative; Surgery; Opioid Use

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

MgSO4

The treatment group received intravenous magnesium sulfate therapy with a 20% magnesium sulfate regimen, 39mg/kg body weight dissolved in 100ml NaCl in 1 hour intravenously.

Group Type: EXPERIMENTAL

MgSO4

Intervention Type: DRUG

The treatment group who received intravenous magnesium sulfate therapy with 20% magnesium sulfate regimen, 30mg/kg body weight dissolved in 100ml NaCl in 1 hour intravenously

Placebo

The treatment group who received intravenous placebo therapy with a regimen of 100 ml NaCl in 1 hour intravenous

Group Type: PLACEBO_COMPARATOR

MgSO4

Intervention Type: DRUG

The treatment group who received intravenous magnesium sulfate therapy with 20% magnesium sulfate regimen, 30mg/kg body weight dissolved in 100ml NaCl in 1 hour intravenously

Interventions

MgSO4

The treatment group who received intravenous magnesium sulfate therapy with 20% magnesium sulfate regimen, 30mg/kg body weight dissolved in 100ml NaCl in 1 hour intravenously

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients undergoing lower extremity orthopedic surgery under general anaesthesia.
• Patients aged 18-60 years.
• Physical status ASA 1-3
• Willing to participate in research.

Exclusion Criteria

• Patients who are hemodynamically unstable.
• Patients with decreased renal function
• Patients with skeletal muscle disorders.
• Patients with Ketorolac allergy
• Patients with morphine allergy

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Aida Rosita Tantri

PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

IndonesiaUAnes124

Identifier Type: -

Identifier Source: org_study_id