Opioid Sparing Anesthesia in Patients With Liver Cirrhosis Undergoing Liver Resection

NCT05674877 | Completed Phase 3

• 1 other identifier: 00309/2022
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

This randomized clinical trial will investigate the opioid sparing effect of dexmedetomidine and ketmine infusion in cirrhotic patients undergoing liver resection

Conditions

Liver Cirrhosis

Keywords

Dexmedetomidine; ketamine; Liver cirrhosis

Outcome Measures

Primary Outcomes (1)

• Intraoperative fentanyl requirements

  Intraoperative fentanyl requirements in micrograms

  Through operative time

Secondary Outcomes (11)

• Postoperative PCA fentanyl requirements

  Postoperative over 48 hours

• Incidence of severe postoperative opioid related adverse events

  48 hours after extubation

• Incidence of bradycardia

  Through operative time

• Incidence of hypotension

  Through operative time

• Incidence of hypertension

  Through operative time

Study Arms (2)

Opioid-based group (OB)

PLACEBO COMPARATOR

.Patients in the opioid-based group will receive placebo boluses and infusions of saline. The intra-operative hemodynamics target will be to maintain the mean arterial blood pressure and heart rate within 20% of baseline value. Significant hemodynamic alterations will be managed as follows: Hypertension and/or tachycardia defined as more than 20% increase of the baseline readings will be managed by top-up doses of fentanyl 1µg/kg

Drug: Opioid-based group (OB) (placebo/saline)

Opioid sparing group (OS)

ACTIVE COMPARATOR

Patients in the Opioid Sparing group will receive a loading dose of dexmedetomidine (1µg/kg over 10 minutes). This will be followed by a fixed continuous maintenance infusion of 0.5µg/kg/hour. Furthermore, a single induction analgesic dose of 0.5 mg/kg ketamine will be given to all patients in the OS group. This will be followed by 0.25 mg/kg/h continuous maintenance infusion. Dexmedetomidine and ketamine infusions will be stopped 30 minutes prior to the conclusion of surgery. The intra-operative hemodynamics target will be to maintain the mean arterial blood pressure and heart rate within 20% of baseline value. Significant hemodynamic alterations will be managed as follows: Hypertension and/or tachycardia defined as more than 20% increase of the baseline readings will be managed by top-up doses of fentanyl 1µg/kg in the two study groups.

Drug: Opioid sparing group (OS) (dexmedetomidine (PRECEDEX™ "dexmedetomidine hydrochloride" - Pfizer) and ketamine)

Interventions

Opioid-based group (OB) (placebo/saline) DRUG

Patients in the opioid-based group will receive placebo boluses and infusions of saline.

Also known as: OB

Opioid-based group (OB)

Opioid sparing group (OS) (dexmedetomidine (PRECEDEX™ "dexmedetomidine hydrochloride" - Pfizer) and ketamine) DRUG

Patients in the Opioid Sparing group will receive a dexmedetomidine (PRECEDEX™ "dexmedetomidine hydrochloride" - Pfizer) and ketamine.

Also known as: OS

Opioid sparing group (OS)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients with liver cirrhosis \[Child A\] aged 18 to 65 years undergoing liver resection.
• American Society of Anesthesiologists class II-III.

You may not qualify if:

• Renal or cardiac dysfunction
• History of chronic pain
• Alcohol or drug abuse
• Analgesic use in last 24 hours before surgery
• Major intraoperative hemodynamic instability
• The need for postoperative ventilation
• Psychiatric disorders
• Inability to comprehend pain assessment
• Allergy or contraindication to any of the study medications.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

National Liver Institute, Menoufia University

Shibīn al Kawm, Egypt

Location

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Sodium Chloride; Dexmedetomidine

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Mohamed C Ollaek

  Department of Anesthesia, Surgical ICU and Pain Management

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 9, 2023
• Study Start: December 1, 2022
• Primary Completion: June 28, 2023
• Study Completion: July 30, 2023
• Last Updated: August 8, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)