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

NCT ID: NCT06473896

Last Updated: 2024-08-07

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-18
• Study Completion Date: 2026-08-30

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

Detailed Description

Analgesia is one of the pillars of anesthesia. For many years, opiates were the basic ingredient in pain relief. The effectiveness of these substances in pain relief caused them to be overused which resulted in a global epidemic of addiction, morbidity and mortality due to the overuse of these drugs. Some of the options for realizing a reduction in the use of opiates include the use of drugs with a more predictable pharmacological profile and a short half-life, such as Remifentanil. This opiate is stronger than Morphine and its half-life remains within a few minutes, without accumulation even after prolonged infusion. Therefore, it seems that the use of remifentanil is ideal, especially for prolonged anesthesia.

One of the severe complications following treatment with Remifentanil is the appearance of increased sensitivity to pain [hyperalgesia] which results from a central sensitivity to pain and is expressed by stimulation of sensory receptors for pain in the nervous system (nociceptive sensitization). In order to alleviate the feeling of pain following the increased sensitivity to pain after treatment with opiates, as well as with Remifentanil, complementary treatments, such as Ketalar and dexmedetomidine, were offered. This study will compare the ability of Ketalar or Dexmedetomidine in alleviating increased sensitivity to pain after treatment with Remifentanil in patients who are candidates for laparoscopic cholecystectomy.

Conditions

Cholecystectomy

Study Design

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

Study Groups

Ketalar

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.

Group Type: ACTIVE_COMPARATOR

Ketalar

Intervention Type: DRUG

a dissociative anesthetic used medically for induction and maintenance of anesthesia

Dexmedetomidine

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.

Group Type: ACTIVE_COMPARATOR

Dexmedetomidine

Intervention Type: DRUG

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

Interventions

Ketalar

a dissociative anesthetic used medically for induction and maintenance of anesthesia

Intervention Type: DRUG

Dexmedetomidine

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

Intervention Type: DRUG

Other Intervention Names

Ketamine; Precedex

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assaf-Harofeh Medical Center

OTHER_GOV

Sponsor Role: lead

Responsible Party

Zoya Haitov Ben Zikri

Manager of the anesthesia unit

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara Bar Yehuda, PhD

Role: STUDY_DIRECTOR

Shamir (Asaf Harofe) medical center

Locations

Shamir (Asaf Harofe) Medical Center

Be’er Ya‘aqov, , Israel

Site Status: RECRUITING

Countries

Israel

Central Contacts

Sara Bar Yehuda, PhD

Role: CONTACT

sarabar1@shamir.gov.il

972528981004

Zoya Haitov Ben Zikri, MD

Role: CONTACT

ZoyaC@shamir.gov.il

972537346186

Facility Contacts

Sara Bar Yehuda, PhD

Role: primary

sarabar1@shamur.gov.il

972528981004

Zoya Haitov Ben Zikri, MD

Role: backup

ZoyaC@shamir.gov.il

972537346186

Other Identifiers

0173-23-ASF

Identifier Type: -

Identifier Source: org_study_id