Effects Of Additional MgSO4 30 Mg/KgBW Intravenous and Ketorolac

Sponsor

Indonesia University (Other)

Overall Status

Completed

CT.gov ID

NCT05609955

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

4.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anesthesia Pain, Postoperative Surgery Opioid Use	Drug: MgSO4	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

48 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Investigator)

Primary Purpose:

Treatment

Official Title:

Effects Of Additional MgSO4 30 Mg/KgBW Intravenous and Ketorolac : Study to Assess Pain And Opioid Consumption in Post Lower Extremity Orthopedic Surgery

Actual Study Start Date :

Jan 1, 2022

Actual Primary Completion Date :

Oct 1, 2022

Actual Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: 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
Placebo Comparator: Placebo The treatment group who received intravenous placebo therapy with a regimen of 100 ml NaCl in 1 hour intravenous	Drug: 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

Arm

Intervention/Treatment

Experimental: 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.

Drug: 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

Placebo Comparator: Placebo

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

Drug: 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

Outcome Measures

Primary Outcome Measures

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

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cipto Mangunkusumo Cental National Hospital	Jakarta	DKI Jakarta	Indonesia	10430

Sponsors and Collaborators

Indonesia University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aida Rosita Tantri, PhD, Indonesia University

ClinicalTrials.gov Identifier:

NCT05609955

Other Study ID Numbers:

IndonesiaUAnes124

First Posted:

Nov 8, 2022

Last Update Posted:

Nov 8, 2022

Last Verified:

Nov 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Pain, Postoperative

Study Results

No Results Posted as of Nov 8, 2022