Intravenous Ketamine Infusion on Postoperative Analgesia of Living Liver Donors

NCT05441150 | Unknown Phase 4

• 1 other identifier: Ketamin-Postopanalgesia
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Failure; Liver Transplant; Complications; Post Operative Pain

Keywords

Living liver donor; Liver; Transplantation; postoperative pain; ketamine

Outcome Measures

Primary Outcomes (1)

• 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.

  24 hour

Secondary Outcomes (2)

• Postop Sedation Score

  Postoperative 1 hour

• postoperative complications

  24 hour

Study Arms (2)

Ketamine Group

ACTIVE COMPARATOR

Patients who received low-dose ketamine infusion

Drug: Low dose ketamine infusion

Control group

SHAM COMPARATOR

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

Drug: 0.9% NaCl infusion

Interventions

Low dose ketamine infusion DRUG

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

Also known as: Ketamine

Ketamine Group

0.9% NaCl infusion DRUG

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

Also known as: Saline

Control group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Inonu University: lead

Study Sites (1)

Inonu university

Malatya, 044100, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Liver Failure; Pain, Postoperative

Interventions

Ketamine; Sodium Chloride

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Nucin Gulhas, Prof.

CONTACT

+90 4223410660; nurcin.gulhas@inonu.edu.tr

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Inonu University, School of Medicine, Department of Anaesthesiology and ReanimationMalatya, Turkey

Study Record Dates

• First Submitted: June 28, 2022
• First Posted: July 1, 2022
• Study Start: June 1, 2022
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2022
• Last Updated: July 5, 2022

Record last verified: 2022-07

Locations

TU (1)