Analgesic Effect of Ketamine Vs Ketamine Magnesium Infusion and Their Effect on Postoperative Morphine Consumption

Phase 1

Completed

• Conditions: Nephrectomy
• Interventions: Drug: Ketamine

• Registration Number: NCT05596669
• Lead Sponsor: Egymedicalpedia

Brief Summary

Ketamine and magnesium-ketamine are two analgesics that are being studied for use as adjuvants. They were shown to have anaesthetic and analgesic properties, and as a consequence of this finding, it has been postulated that they may have a role in minimising the requirement for analgesic drugs during the postoperative period. The major objective of the research was to examine the pain-relieving effects of ketamine vs ketamine magnesium infusion, as well as their influence on postoperative morphine consumption following nephrectomy; the secondary goal is to assess hemodynamic effects and pain severity.

Detailed Description

Renal necrosis factor (RN) therapy, which includes ipsilateral adrenalectomy, was first utilized to treat renal cortical tumours in 1969. A radical nephrectomy is a surgical surgery in which the whole kidney, as well as the surrounding fat and, in some cases, the adrenal gland and lymph nodes, are removed. This operation is carried out as an inpatient .

Opioid use, on the other hand, can result in considerable side effects and adverse events, which can result in much longer hospital stays and higher postsurgical hospital costs. Although opioid-based analgesia is essential for postoperative pain management, opioid usage may have serious adverse effects .

Finding techniques to limit opioid intake in the postoperative period is essential because cases that got increased opioid dosages are more likely to have the negative effects. Using non-opioid analgesics alongside opioid analgesics, known as analgesia of multi-modes, to enhance post-operative pain management while reducing the usage of the opioids. .

Ketamine, also and magnesium-ketamine are two analgesics wich are non-opioid that are being studied for use like opioid analgesic adjuvants. They were discovered to have anaesthetic and analgesic properties, and it has been proposed that as a result of this discovery, they may have a great contribution in reducing the need for postoperative analgesic medications .

Study Timeline

• Study Start: 2021-09-01
• Primary Completion: 2022-05-01
• Study Completion: 2022-05-15
• Status Verified: 2022-10
• Study First Submitted: 2022-10-24
• Study First Submitted QC: 2022-10-24
• Last Update Submitted: 2022-10-24
• Study First Posted: 2022-10-27
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Patients with elective nephrectomy

Exclusion Criteria

• Pregnant women
• Cases with severe chronic disease as liver cell failures, CHF
• cases with allergies to ketamine and magnesium sulphate
• cases with a history of current regular use of (analgesic, anticonvulsant, antidepressant)
• chronic pain.
• mental illness.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Effect of Ketamine Magnesium on Postoperative Morphine Consumption	Ketamine	cases in Group II received Ketamine Magnesium group were given a continuous infusion of (0.15mg/kg/h) of ketamine and (10mg/kg/h) of magnesium
Effect of Ketamine on Postoperative Morphine Consumption	Ketamine	cases in Group I received infusion of 0.15 mg/kg/h for the duration. Following a parenteral bolus dose of magnesium and ketamine (0.3mg/kg),

Primary Outcome Measures

Name	Time	Method
Measurement of Post-operative Pain	24-hour analgesic after nephrectomy	Assessment of the pain post-operatively in patients with pain score as : Total scores vary from 0 to 10 in this method, with a higher score indicating more severe pain,The Ramsay sedation scale was utilized to gauge postoperative sedation levels.

Trial Locations

Locations (1)

October 6 University Hospital; 🇪🇬 Giza, Egypt