Intravenous Ketamine Infusion on Postoperative Analgesia of Living Liver Donors

Effect of Intraoperative Intravenous Ketamine Infusion on Postoperative Analgesia in Right Hepatectomy of Living Liver Donors

Sponsors

Lead Sponsor: Inonu University

Source Inonu University
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.

Overall Status Recruiting
Start Date 2022-06-01
Completion Date 2022-11-01
Primary Completion Date 2022-10-01
Phase Phase 4
Study Type Interventional
Primary Outcome
Measure Time Frame
Postoperative opioid consumption 24 hour
Secondary Outcome
Measure Time Frame
Postop Sedation Score Postoperative 1 hour
postoperative complications 24 hour
Enrollment 2
Condition
Intervention

Intervention Type: Drug

Intervention Name: Low dose ketamine infusion

Description: Administering low-dose ketamine infusion to the patient under general anesthesia for Ketamine Group.

Arm Group Label: Ketamine Group

Other Name: Ketamine

Intervention Type: Drug

Intervention Name: 0.9% NaCl infusion

Description: Same dose of 0.9% NaCl infusion as the dose of ketamine for Control Group.

Arm Group Label: Control group

Other Name: Saline

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).

Gender:

All

Minimum Age:

18 Years

Maximum Age:

65 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Contact

Last Name: Nucin Gulhas, Prof.

Phone: +90 4223410660

Phone Ext.: 3121

Email: [email protected]

Location
Facility: Status: Contact: Inonu university Mehmet A Erdogan, MD +904223410660 [email protected]
Location Countries

Turkey

Verification Date

2022-07-01

Responsible Party

Type: Principal Investigator

Investigator Affiliation: Inonu University

Investigator Full Name: Mehmet Ali Erdoğan

Investigator Title: Inonu University, School of Medicine, Department of Anaesthesiology and ReanimationMalatya, Turkey

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Ketamine Group

Type: Active Comparator

Description: Patients who received low-dose ketamine infusion

Label: Control group

Type: Sham Comparator

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

Patient Data Undecided
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Prevention

Masking: Single (Investigator)

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