Effects Of Additional MgSO4 30 Mg/KgBW Intravenous and Ketorolac

NCT05609955 | Completed Phase 4 DMC

• 1 other identifier: IndonesiaUAnes124
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Anesthesia; Pain, Postoperative; Surgery; Opioid Use

Outcome Measures

Primary Outcomes (1)

• Visual analogue scale

  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.

  24 hour

Secondary Outcomes (1)

• Morphine consumption

  24 hour

Study Arms (2)

MgSO4

EXPERIMENTAL

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.

Drug: MgSO4

Placebo

PLACEBO COMPARATOR

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

Drug: MgSO4

Interventions

MgSO4 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

MgSO4; Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo Cental National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD

Study Record Dates

• First Submitted: November 2, 2022
• First Posted: November 8, 2022
• Study Start: January 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2022
• Last Updated: November 8, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)