Clinical trial

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

Name
MagSulf1234
Description
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.
Trial arms
Trial start
2024-03-03
Estimated PCD
2024-06-01
Trial end
2024-10-01
Status
Recruiting
Phase
Early phase I
Treatment
Magnesium sulfate
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
Arms:
Group M
Other names:
Magnesium sulphate
Normal Saline
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
Arms:
Group C
Other names:
NS
Size
42
Primary endpoint
To evaluate the efficacy of magnesium sulphate for post-operative pain
At 0, 1, 6,12 18 and 24 hours post-operatively
Eligibility criteria
Inclusion Criteria: * Patient undergoing elective abdominal hysterectomy. * Between the ages of 18- 65. * American Society of Anesthesiologists Physical Status (ASA PS) I and II. Exclusion Criteria: * Neurological and psychiatric disorder. * Drug or alcohol abuse. * Patients with a known or suspected allergy to magnesium sulphate. * Patients with any contraindication to magnesium sulphate (heart blocks, neuromuscular diseases)
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}}, 'enrollmentInfo': {'count': 42, 'type': 'ESTIMATED'}}
Updated at
2024-04-11

1 organization

2 products

1 indication