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Effects Of Additional MgSO4 30 Mg/KgBW Intravenous and Ketorolac

Primary Purpose

Anesthesia, Pain, Postoperative, Surgery

Status
Completed
Phase
Phase 4
Locations
Indonesia
Study Type
Interventional
Intervention
MgSO4
Sponsored by
Indonesia University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anesthesia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

  • Cipto Mangunkusumo Cental National Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MgSO4

Placebo

Arm 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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 2, 2022
Last Updated
November 2, 2022
Sponsor
Indonesia University
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1. Study Identification

Unique Protocol Identification Number
NCT05609955
Brief Title
Effects Of Additional MgSO4 30 Mg/KgBW Intravenous and Ketorolac
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 1, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Actual)
Study Completion Date
November 1, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indonesia University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anesthesia, Pain, Postoperative, Surgery, Opioid Use

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MgSO4
Arm Type
Experimental
Arm 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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The treatment group who received intravenous placebo therapy with a regimen of 100 ml NaCl in 1 hour intravenous
Intervention Type
Drug
Intervention Name(s)
MgSO4
Intervention Description
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
Primary Outcome Measure Information:
Title
Visual analogue scale
Description
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.
Time Frame
24 hour
Secondary Outcome Measure Information:
Title
Morphine consumption
Description
The number of milligrams (mg) of intravenous morphine in the first 24 hours postoperatively using a PCA device.
Time Frame
24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Facility Information:
Facility Name
Cipto Mangunkusumo Cental National Hospital
City
Jakarta
State/Province
DKI Jakarta
ZIP/Postal Code
10430
Country
Indonesia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects Of Additional MgSO4 30 Mg/KgBW Intravenous and Ketorolac

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