Effect of Ketalar or Dexmedetomidine on Increased Sensitivity to Pain Following Treatment With Remifentanil

NCT06473896 | Recruiting

• 1 other identifier: 0173-23-ASF
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

Analgesia is one of the pillars of anesthesia. One of the common opiates for pain relief, with a short half-life, is Remifentanil. However, following Remifentanil treatment an increased sensitivity to pain \[hyperalgesia\] appears. The aim of the study is to compare the effects between complementary treatments, like Ketalar and Dexmedetomidine, in preventing increased sensitivity to pain after Remifentanil treatment

Conditions

Cholecystectomy

Outcome Measures

Primary Outcomes (2)

• Pain Level

  A record of pain level will be made using the Visual Analogue Scale. The score is determined by marking on 10-cm line between 0 - "no pain" to 10 - "the highest pain".

  Up to two hours after the end of the anesthesia process

• Pain killer consumption

  Treatment with morphine for pain relief

  Up to two hours after the end of the anesthesia process

Study Arms (2)

Ketalar

ACTIVE COMPARATOR

All patients will undergo general anesthesia using Fentanyl at a dose of 2 mcg/kg, Rocuronium at a dose of 0.6 mg/kg, Isoflurane during surgery and Remifentanil at a dose of 0.2-0.25 mcg/kg/min, 30 Minutes before the end of the operation, Morphine will be given at a dose of 0.1 mg/kg. Each patient will receive paracetamol during surgery. In addition to the general anesthesia, the patients in the Ketalar group will also receive a bolus of Ketalar at a dose of 0.3 mg/kg in induction + Propofol and Fentanyl and during the operation, continuous Ketalar at a dose of 5 mcg/kg/minute.

Drug: Ketalar

Dexmedetomidine

ACTIVE COMPARATOR

In addition to the general anesthesia, the patients in the Dexmedetomidine group will also receive a bolus of Ketalar at a dose of 0.3 mg/kg in induction + Propofol and Fentanyl and during the operation, continuous Ketalar at a dose of 5 mcg/kg/minute. In addition to the general anesthesia, the patients in the Dexmedetomidine group will also receive a bolus of Dexmedetomidine at a dose of 0.5 mg/kg for fifteen minutes + Propofol and Fentanyl, and during the operation, continuous Dexmedetomidine at a dose of 0.3 mcg/kg/hour.

Drug: Dexmedetomidine

Interventions

Ketalar DRUG

a dissociative anesthetic used medically for induction and maintenance of anesthesia

Also known as: Ketamine

Ketalar

Dexmedetomidine DRUG

an agonist of α2-adrenergic receptors in certain parts of the brain used for sedation

Also known as: Precedex

Dexmedetomidine

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who are about to undergo alaparoscopic cholecystectomy under general anesthesia

You may not qualify if:

• Patients with sensitivity to the anesthetic
• Patients with chronic pain who are in regular treatment
• Urgent surgery
• Patients with ischemic heart disease
• Patients with known bradycardia
• Patients with a pacemaker
• Prolonged use of opiates
• Kidney/liver function problems

Sponsors & Collaborators

• Assaf-Harofeh Medical Center: lead

Study Sites (1)

Shamir (Asaf Harofe) Medical Center

Be’er Ya‘aqov, 70300, Israel

RECRUITING

MeSH Terms

Interventions

Ketamine; Dexmedetomidine

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Sara Bar Yehuda, PhD

  Shamir (Asaf Harofe) medical center

  STUDY DIRECTOR

Central Study Contacts

Sara Bar Yehuda, PhD

CONTACT

972528981004; sarabar1@shamir.gov.il

Zoya Haitov Ben Zikri, MD

CONTACT

972537346186; ZoyaC@shamir.gov.il

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: The patients will not be exposed to the treatment arm they will receive
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Manager of the anesthesia unit

Model Details: The patients will be classified into 2 groups: The Ketalar group - who will receive, in addition to the general anesthesia, a bolus of Ketalar during induction and during the operation, continuous ketamine. The Dexmedetomidine group - in addition to the general anesthesia, they will also receive a Dexmedetomidine bolus in the induction and during the operation continuous Dexmedetomidine

Study Record Dates

• First Submitted: June 19, 2024
• First Posted: June 25, 2024
• Study Start: April 18, 2024
• Primary Completion: April 30, 2026
• Study Completion (Estimated): August 30, 2026
• Last Updated: August 7, 2024

Record last verified: 2024-08

Locations

IL (1)