Intravenous Ketamine Infusion on Postoperative Analgesia of Living Liver Donors

NCT ID: NCT05441150

Last Updated: 2022-07-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 2 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-06-01
• Study Completion Date: 2022-11-01

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.

Conditions

Liver Failure; Liver Transplant; Complications; Post Operative Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Ketamine Group

Patients who received low-dose ketamine infusion

Group Type: ACTIVE_COMPARATOR

Low dose ketamine infusion

Intervention Type: DRUG

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

Control group

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

Group Type: SHAM_COMPARATOR

0.9% NaCl infusion

Intervention Type: DRUG

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

Interventions

Low dose ketamine infusion

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

Intervention Type: DRUG

0.9% NaCl infusion

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

Intervention Type: DRUG

Other Intervention Names

Ketamine; 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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Inonu University

OTHER

Sponsor Role: lead

Responsible Party

Mehmet Ali Erdoğan

Inonu University, School of Medicine, Department of Anaesthesiology and ReanimationMalatya, Turkey

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Inonu university

Malatya, , Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Nucin Gulhas, Prof.

Role: CONTACT

nurcin.gulhas@inonu.edu.tr

+90 4223410660 ext. 3121

Facility Contacts

Mehmet A Erdogan, MD

Role: primary

drmalierdogan@gmail.com

+904223410660

Other Identifiers

Ketamin-Postopanalgesia

Identifier Type: -

Identifier Source: org_study_id