Intravenous Ketamine Infusion on Postoperative Analgesia of Living Liver Donors

Post Operative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05441150
• Other study ID #: Ketamin-Postopanalgesia
• Status: Recruiting
• Phase: Phase 4
• Start date: June 1, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: July 2022
• Source: Inonu University
• Contact: Nucin Gulhas, Prof.
• Phone: +90 4223410660
• Email: nurcin.gulhas[@]inonu.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2
• Est. completion date: November 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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).

Related Conditions & MeSH terms

• Liver Failure
• Liver Transplant; Complications
• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• Low dose ketamine infusion
Administering low-dose ketamine infusion to the patient under general anesthesia for Ketamine Group.
• 0.9% NaCl infusion
Same dose of 0.9% NaCl infusion as the dose of ketamine for Control Group.

Locations

Country	Name	City	State
Turkey	Inonu university	Malatya

Sponsors (1)

Lead Sponsor	Collaborator
Inonu University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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 1 hour
Secondary	postoperative complications	postoperative complications: pruritus, vomiting, hallucination	24 hour