Effects Of Additional MgSO4 30 Mg/KgBW Intravenous and Ketorolac

University of Indonesia (UI)

Status and phase: Completed; Phase 4

Conditions: Surgery; Pain, Postoperative; Opioid Use; Anesthesia

Treatments: Drug: MgSO4

Study type: Interventional

Funder types: Other

Identifiers

NCT05609955

IndonesiaUAnes124

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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48 participants in 2 patient groups, including a placebo group

MgSO4

Experimental group

Description:

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.

Treatment:

Drug: MgSO4

Placebo

Placebo Comparator group

Description:

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

Treatment:

Drug: MgSO4