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

Sponsor
Egymedicalpedia (Industry)
Overall Status
Completed
CT.gov ID
NCT05596669
Collaborator
(none)
100
1
2
8.4
11.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
100 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Assessment of Analgesic Effect of Ketamine Vs Ketamine Magnesium Infusion and Their Effect on Postoperative Morphine Consumption After Surgical Nephrectomy
Actual Study Start Date :
Sep 1, 2021
Actual Primary Completion Date :
May 1, 2022
Actual Study Completion Date :
May 15, 2022

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Effect of Ketamine on Postoperative Morphine Consumption

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
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
Other Names:
  • Ketamine Magnesium
  • Morphine
  • Active Comparator: Effect of Ketamine Magnesium on Postoperative Morphine Consumption

    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
    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
    Other Names:
  • Ketamine Magnesium
  • Morphine
  • Outcome Measures

    Primary Outcome Measures

    1. 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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 50 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 October 6 University Hospital Giza Egypt

    Sponsors and Collaborators

    • Egymedicalpedia

    Investigators

    • Principal Investigator: Nirvana Elshalakany, Professor, Department of Anesthesia and I.C.U. faculty of Medicine October six university, Egypt

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Egymedicalpedia
    ClinicalTrials.gov Identifier:
    NCT05596669
    Other Study ID Numbers:
    • Nirvana Ahmed 02
    First Posted:
    Oct 27, 2022
    Last Update Posted:
    Oct 27, 2022
    Last Verified:
    Oct 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Egymedicalpedia
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 27, 2022