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Intravenous Ketamine Infusion on Postoperative Analgesia of Living Liver Donors

Primary Purpose

Liver Failure, Liver Transplant; Complications, Post Operative Pain

Status
Recruiting
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Low dose ketamine infusion
0.9% NaCl infusion
Sponsored by
Inonu University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Liver Failure focused on measuring Living liver donor, Liver, Transplantation, postoperative pain, ketamine

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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).

Sites / Locations

  • Inonu universityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Ketamine Group

Control group

Arm Description

Patients who received low-dose ketamine infusion

Patients who received 0.9% Sodium Chloride Solution, Intravenous, (NaCl) infusion

Outcomes

Primary Outcome Measures

Postoperative opioid consumption
To determine the cumulative opioid consumption at the end of 24 hours in patients who received low-dose ketamine or 0.9% NaCl infusion.

Secondary Outcome Measures

Postop Sedation Score
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
postoperative complications: pruritus, vomiting, hallucination

Full Information

First Posted
June 28, 2022
Last Updated
July 1, 2022
Sponsor
Inonu University
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1. Study Identification

Unique Protocol Identification Number
NCT05441150
Brief Title
Intravenous Ketamine Infusion on Postoperative Analgesia of Living Liver Donors
Official Title
Effect of Intraoperative Intravenous Ketamine Infusion on Postoperative Analgesia in Right Hepatectomy of Living Liver Donors
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 1, 2022 (Actual)
Primary Completion Date
October 1, 2022 (Anticipated)
Study Completion Date
November 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Inonu University

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Liver Failure, Liver Transplant; Complications, Post Operative Pain
Keywords
Living liver donor, Liver, Transplantation, postoperative pain, ketamine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
2 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ketamine Group
Arm Type
Active Comparator
Arm Description
Patients who received low-dose ketamine infusion
Arm Title
Control group
Arm Type
Sham Comparator
Arm Description
Patients who received 0.9% Sodium Chloride Solution, Intravenous, (NaCl) infusion
Intervention Type
Drug
Intervention Name(s)
Low dose ketamine infusion
Other Intervention Name(s)
Ketamine
Intervention Description
Administering low-dose ketamine infusion to the patient under general anesthesia for Ketamine Group.
Intervention Type
Drug
Intervention Name(s)
0.9% NaCl infusion
Other Intervention Name(s)
Saline
Intervention Description
Same dose of 0.9% NaCl infusion as the dose of ketamine for Control Group.
Primary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
To determine the cumulative opioid consumption at the end of 24 hours in patients who received low-dose ketamine or 0.9% NaCl infusion.
Time Frame
24 hour
Secondary Outcome Measure Information:
Title
Postop Sedation Score
Description
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
Time Frame
Postoperative 1 hour
Title
postoperative complications
Description
postoperative complications: pruritus, vomiting, hallucination
Time Frame
24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nucin Gulhas, Prof.
Phone
+90 4223410660
Ext
3121
Email
nurcin.gulhas@inonu.edu.tr
Facility Information:
Facility Name
Inonu university
City
Malatya
ZIP/Postal Code
044100
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mehmet A Erdogan, MD
Phone
+904223410660
Email
drmalierdogan@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
Undecided
IPD Sharing Plan Description
I am hesitant to share the data before completing the study. However after end of the study I might consider sharing

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Intravenous Ketamine Infusion on Postoperative Analgesia of Living Liver Donors

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