Effects Of Additional MgSO4 30 Mg/KgBW Intravenous and Ketorolac

Surgery Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05609955
• Other study ID #: IndonesiaUAnes124
• Status: Completed
• Phase: Phase 4
• Start date: January 1, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: November 2022
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: November 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Opioid Use
• Pain, Postoperative
• Surgery

Intervention

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

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Cental National Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Indonesia University

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Morphine consumption	The number of milligrams (mg) of intravenous morphine in the first 24 hours postoperatively using a PCA device.	24 hour