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

NCT05596669 | Completed Phase 1 DMC

• 1 other identifier: Nirvana Ahmed 02
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Nephrectomy

Keywords

Ketamine; Ketamine Magnesium,; Analgesic,; morphine consumption,; Nephrectomy

Outcome Measures

Primary Outcomes (1)

• Measurement of Post-operative Pain

  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.

  24-hour analgesic after nephrectomy

Study Arms (2)

Effect of Ketamine on Postoperative Morphine Consumption

ACTIVE COMPARATOR

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),

Drug: Ketamine

Effect of Ketamine Magnesium on Postoperative Morphine Consumption

ACTIVE COMPARATOR

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

Drug: Ketamine

Interventions

Ketamine DRUG

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

Also known as: Ketamine Magnesium, Morphine

Effect of Ketamine Magnesium on Postoperative Morphine Consumption; Effect of Ketamine on Postoperative Morphine Consumption

Eligibility Criteria

• Age: 35 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Patients with elective nephrectomy

You may not qualify if:

• 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.

Sponsors & Collaborators

• Egymedicalpedia: lead

Study Sites (1)

October 6 University Hospital

Giza, Egypt

Location

MeSH Terms

Interventions

Ketamine; Morphine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Nirvana Elshalakany, Professor

  Department of Anesthesia and I.C.U. faculty of Medicine October six university, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 24, 2022
• First Posted: October 27, 2022
• Study Start: September 1, 2021
• Primary Completion: May 1, 2022
• Study Completion: May 15, 2022
• Last Updated: October 27, 2022

Record last verified: 2022-10

Locations

EG (1)