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Intravenous Ketamine Infusion on Postoperative Analgesia of Living Liver Donors

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ClinicalTrials.gov Identifier: NCT05441150
Recruitment Status : Recruiting
First Posted : July 1, 2022
Last Update Posted : July 5, 2022
Sponsor:
Information provided by (Responsible Party):
Mehmet Ali Erdoğan, Inonu University

Tracking Information
First Submitted Date  ICMJE June 28, 2022
First Posted Date  ICMJE July 1, 2022
Last Update Posted Date July 5, 2022
Actual Study Start Date  ICMJE June 1, 2022
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2022)
Postoperative opioid consumption [ Time Frame: 24 hour ]
To determine the cumulative opioid consumption at the end of 24 hours in patients who received low-dose ketamine or 0.9% NaCl infusion.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 28, 2022)
  • Postop Sedation Score [ Time Frame: Postoperative 1 hour ]
    Postop Sedation Score (0-3): sedation was measured on a scale of 0 to 3 0: fully awake; 1: lightly sedated, rarely sleepy and easily aroused; 2: moderately sedated, often sleepy and easily aroused; 3; severely sedated, sleepy and difficult to wake up
  • postoperative complications [ Time Frame: 24 hour ]
    postoperative complications: pruritus, vomiting, hallucination
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Intravenous Ketamine Infusion on Postoperative Analgesia of Living Liver Donors
Official Title  ICMJE Effect of Intraoperative Intravenous Ketamine Infusion on Postoperative Analgesia in Right Hepatectomy of Living Liver Donors
Brief Summary

Because of the insufficiency of cadaveric organs and increasing need for organs, the interest in living donor liver transplantation have been greatly increased. The relative reduction of the remaining liver after the operation in Living Liver Donors makes it difficult and compelling to choose a very effective and very safe method in the management of postoperative analgesia.

Opioids are the main agents used in the postoperative analgesia of Live Liver Donors. Opioids have serious side effects such as respiratory depression, apnea, circulatory collapse, coma, and death. Both short-term and long-term administration of opioids cause acute opioid-induced hyperalgesia.

Ketamine, an NMDA receptor antagonist, has been hypothesized to counter opioid tolerance and NMDA receptor-mediated central sensitization. Various studies and systematic reviews have shown that low-dose ketamine has an opioid-sparing effect in all surgical patients.

Although low-dose ketamine has been shown to be beneficial overall in relieving pain, it is unclear whether it has an identified benefit in hepatectomy cases. The aim of this clinical trial was to evaluate the effect of low-dose ketamine administration on postoperative analgesia in living donor liver donors undergoing right hepatectomy procedure.

Detailed Description

Liver transplantation is the only treatment for end-stage liver failure. The insufficiency of cadaveric organs and the inability to meet the increasing need for organs with cadaveric transplantations have greatly increased the interest in living donor liver transplantation. The relative reduction of the remaining liver after the operation in Living Liver Donors makes it difficult and compelling to choose a very effective and very safe method in the management of postoperative analgesia.

Opioids are the main agents used in the postoperative analgesia of Live Liver Donors. Opioids have serious side effects such as respiratory depression, apnea, circulatory collapse, coma, and death. Both short-term and long-term administration of opioids cause acute opioid-induced hyperalgesia.

There is evidence that opioid tolerance can occur in the dorsal root ganglion through N-methyl-D-aspartate (NMDA) receptor activation. Ketamine, an NMDA receptor antagonist, has been hypothesized to counter opioid tolerance and NMDA receptor-mediated central sensitization. Low-dose ketamine is an effective adjuvant in painful orthopedic procedures that reduces pain and opioid need, especially in the first 24 hours after the procedure. Various studies and systematic reviews have shown that low-dose ketamine has an opioid-sparing effect in all surgical patients.

Although low-dose ketamine has been shown to be beneficial overall in relieving pain, it is unclear whether it has an identified benefit in hepatectomy cases. The aim of this randomized placebo-controlled clinical trial was to evaluate the effect of low-dose ketamine administration on postoperative analgesia in living donor liver donors undergoing a painful right hepatectomy procedure.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Liver Failure
  • Liver Transplant; Complications
  • Post Operative Pain
Intervention  ICMJE
  • Drug: Low dose ketamine infusion
    Administering low-dose ketamine infusion to the patient under general anesthesia for Ketamine Group.
    Other Name: Ketamine
  • Drug: 0.9% NaCl infusion
    Same dose of 0.9% NaCl infusion as the dose of ketamine for Control Group.
    Other Name: Saline
Study Arms  ICMJE
  • Active Comparator: Ketamine Group
    Patients who received low-dose ketamine infusion
    Intervention: Drug: Low dose ketamine infusion
  • Sham Comparator: Control group
    Patients who received 0.9% Sodium Chloride Solution, Intravenous, (NaCl) infusion
    Intervention: Drug: 0.9% NaCl infusion
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 28, 2022)
2
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 1, 2022
Estimated Primary Completion Date October 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • living liver donors, aged 16-65 years, who are scheduled for right hepatectomy will be included in the study.

Exclusion Criteria:

  • to use opioid medications before surgery,
  • trauma,
  • body mass index (BMI) >35,
  • unstable ischemic heart disease,
  • increased intracranial or intraocular pressure,
  • lactation,
  • to have an allergic to ketamine, morphine, propofol or remifentanil,
  • psychiatric illness, patient-controlled analgesia (PCA)
  • unwillingness or inability to use the device
  • inability to use the numerical rating scale (NRS).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Nucin Gulhas, Prof. +90 4223410660 ext 3121 nurcin.gulhas@inonu.edu.tr
Listed Location Countries  ICMJE Turkey
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05441150
Other Study ID Numbers  ICMJE Ketamin-Postopanalgesia
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Plan Description: I am hesitant to share the data before completing the study. However after end of the study I might consider sharing
Current Responsible Party Mehmet Ali Erdoğan, Inonu University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Inonu University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Inonu University
Verification Date July 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP