Effects Of Additional MgSO4 30 Mg/KgBW Intravenous and Ketorolac

Phase 4

Completed

• Conditions: Surgery; Anesthesia; Pain, Postoperative; Opioid Use
• Interventions: Drug: MgSO4

• Registration Number: NCT05609955
• Lead Sponsor: Indonesia University

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.

Study Timeline

• Study Start: 2022-01-01
• Primary Completion: 2022-10-01
• Status Verified: 2022-11
• Study Completion: 2022-11-01
• Study First Submitted: 2022-11-02
• Study First Submitted QC: 2022-11-02
• Last Update Submitted: 2022-11-02
• Study First Posted: 2022-11-08
• Last Update Posted: 2022-11-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MgSO4	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.
Placebo	MgSO4	The treatment group who received intravenous placebo therapy with a regimen of 100 ml NaCl in 1 hour intravenous

Primary Outcome Measures

Name	Time	Method
Visual analogue scale	24 hour	The scale for measuring pain felt by the patient is in the form of a horizontal straight line 100 mm long. In the VAS examination, the patient is asked to point to a point along the line that reflects the degree of pain felt. There is a millimeter ruler for calculating the VAS score. A score of 0 = no pain and a score of 10 = unbearable severe pain.

Secondary Outcome Measures

Name	Time	Method
Morphine consumption	24 hour	The number of milligrams (mg) of intravenous morphine in the first 24 hours postoperatively using a PCA device.

Trial Locations

Locations (1)

Cipto Mangunkusumo Cental National Hospital; 🇮🇩 Jakarta, DKI Jakarta, Indonesia