CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 42 enrolled
Drug / intervention
Magnesium sulfate +1 moredrug
Likely dose
Magnesium sulfate 50 mg/kgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06026527
NCT06026527Phase 3Completed

Intra-operative Magnesium Sulphate for Post-operative Pain in Patients Undergoing Total Abdominal Hysterectomy Under General Anesthesia

Tribhuvan University Teaching Hospital, Institute Of Medicine.·interventional·Posted Sep 7, 2023·Updated Dec 31, 2024

In Brief

A Phase 3 clinical trial evaluating Magnesium sulfate and Normal Saline for Post-operative Pain. Completed, enrolled 42 participants across 1 site.

Detailed Summary

Post-operative pain management is a complex entity. It is one of the most critical parameters in the enhanced recovery after surgery protocol. Adequate postoperative pain relief leads to earlier mobilisation, shortened hospital stay, reduced hospital costs and increased patient satisfaction. For post-operative analgesia, opioids have long been the mainstay of drugs used; however, they produce unwanted side effects, such as respiratory depression, nausea, vomiting and dependence. The major goal in postoperative pain management is to minimise the dose of a single medication and lessen its side effects, while still providing adequate analgesia by the use of multimodal analgesia. Paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), regional techniques like epidural analgesia, different kind of blocks and local wound infiltration are some of the components of multimodal approach to post- operative analgesia. Besides, there are some drugs that may be used as adjuvants to opioids to enhance the analgesic efficacy and facilitate opioid sparing with a reduction in opioid related side effects. Magnesium sulphate, due to its N- Methyl D- Aspartate (NMDA) blocking property, has been studied as one of such non opioid adjuvants. The outcome of many of these studies is in favour of magnesium sulphate but there are negative reports as well. So, in this study the investigators aim to evaluate the efficacy of intra-operative intravenous magnesium sulphate for post-operative pain and opioid use in patients undergoing abdominal hysterectomy under general anaesthesia.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesNepal
Collaborators--

Timeline

Phase 3CompletedFinished
202420252026
First PostedSep 7, 2023
Enrollment StartMar 3, 2024
Primary CompletionSep 30, 2024
Study CompletionOct 30, 2024
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 2.8 years ago

Interventions

Magnesium sulfatedrug

50 mg/kg Magnesium sulphate in 93-95 ml Normal Saline ( making a total of 100 ml solution )will be infused intravenously over 20-30 minutes in the participants allocated to M group starting from the moment of induction of anaesthesia

Normal Salinedrug

100 ml Normal Saline will be infused intravenously over 20-30 minutes in the participants allocated to control group starting from the moment of induction of anaesthesia