Nociception Level During Opioid-sparing Anaesthesia Versus Conventional Opioid-based Anaesthesia

NCT05485480 | Completed

• 1 other identifier: 2022-00283; qu20Bandschapp
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this double blind, randomised controlled non-inferiority trial is to compare the antinociceptive efficiency of an opioid-sparing and a conventional opioid-based anaesthesia protocol with the help of the CEcertificated Pain Monitoring Device (PMD-200).

Conditions

Analgesia

Keywords

analgesia nociception; opioid-sparing anaesthesia; conventional opioid-based anaesthesia; Pain Monitoring Device (PMD-200); intraoperative nociceptive levels; Post operative nausea and vomiting (PONV)

Outcome Measures

Primary Outcomes (1)

• Mean of the nociception level as measured by the PMD-200

  The PMD-200 device consists of a finger probe which continuously assesses pulse rate, pulse rate variability, pulse wave amplitude, skin conductance level, skin conductance fluctuations, skin temperature, and finger motion. A value of 0 corresponds to no pain and a value of 100 to maximal pain. A value will be measured every minute from the timepoint of skin incision until skin closure.

  From the timepoint of skin incision until skin closure (within 1 day)

Secondary Outcomes (11)

• Change in Aldrete score

  Every 15 minutes in recovery until patient discharge to the ward (within 1 day)

• Amount of morphine needed

  From the stay in recovery before discharge from the ward (average of 1 week)

• Amount of ketamine needed

  From the stay in recovery before discharge from the ward (average of 1 week)

• Change in pain score at rest by numeric rating scale

  From the stay in recovery before discharge from the ward (average of 1 week)

• Change in pain score at movement by numeric rating scale

  From the stay in recovery before discharge from the ward (average of 1 week)

Study Arms (2)

Opioid-sparing: Lidocaine, Ketamine, Magnesium, Clonidine, Fentanyl, Remifentanil, Propofol

EXPERIMENTAL

Ketamine: started at 5mg/h; continued until 30min before end of surgery, then reduced to 1mg/h until discharge from recovery. Fentanyl: bolus of 50mcg before skin incision (in case of insufficient analgesia further boluses of 25mcg, upper limit is 100mcg). Lidocaine: bolus of 1.5mg/kg of ideal body weight (IBW),(maximum 100mg) at induction of anaesthesia, then continuous infusion of 1.5mg/kg IBW/h (maximum 100mg/h) until discharge from recovery. Magnesium: infusion of 2g/h for a maximum of 2h after induction of anaesthesia (maximum dose 4g). In case of bradycardia or hypotension, rate is reduced to 1g/h. Clonidine: bolus of 15mcg if needed. Maximum amount 150mcg. Remifentanil: started at time of induction of anaesthesia until end of surgery.

Drug: opioid-sparing group

Conventional group: Fentanyl, Remifentanil, Propofol

ACTIVE COMPARATOR

Control Intervention: Remifentanil: Remifentanil is given as a target controlled infusion using the Minto-model. It is started at the timepoint of induction of anaesthesia and given until the end of surgery. Fentanyl: 2mcg/kg i.v. is given at the time of induction of anaesthesia and another 1-2mcg/kg is given prior to incision. Further fentanyl boluses (1-2mcg/kg boluses) are given in case there seems to be insufficient analgesia.

Drug: conventional opioid-based group

Interventions

conventional opioid-based group DRUG

In addition to propofol as a hypnotic and rocuronium as a muscle relaxant, patients in the conventional opioid-based group will receive the following drugs: Remifentanil and Fentanyl

Conventional group: Fentanyl, Remifentanil, Propofol

opioid-sparing group DRUG

In addition to propofol as a hypnotic and rocuronium as a muscle relaxant, patients in the opioid-sparing group will receive Ketamine, Fentanyl, Lidocaine, Magnesium, Clonidine, Remifentanil

Opioid-sparing: Lidocaine, Ketamine, Magnesium, Clonidine, Fentanyl, Remifentanil, Propofol

Eligibility Criteria

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

You may qualify if:

• Informed Consent as documented by signature
• Age older than 18 years
• Ability to give informed consent
• Undergoing scheduled general surgical, gynaecological or urological laparoscopic surgery
• American Society of Anesthesiology Score (ASA) status I, II, III

You may not qualify if:

• Inability to give informed consent
• ASA status IV and V
• Pregnant or breastfeeding women
• Allergy to one of the study drugs
• Urgent surgery
• Surgery with planned regional anaesthesia
• Outpatient surgery
• Atrioventricular block, intraventricular or sinoatrial block
• Atrial fibrillation
• Sinus bradycardia
• Cardiac insufficiency with a reduced left ventricular ejection fraction of below 40%
• Coronary artery disease
• Epilepsy
• Liver cirrhosis
• Chronic kidney disease (Clearance \< 50ml/h)

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Department of Anaesthesiology, University Hospital Basel

Basel, 4031, Switzerland

Location

MeSH Terms

Conditions

Agnosia; Vomiting

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive

Study Officials

• Thierry Girard, Prof. Dr. med.

  Department of Anaesthesiology, University Hospital Basel

  STUDY DIRECTOR

• Oliver Bandschapp, PD Dr. med.

  Department of Anaesthesiology, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: The patient and the investigator carrying out the nociception level measurement and the postoperative assessments will be blinded to the type of anaesthesia protocol that the patient is allocated to.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Double blind, randomised controlled non-inferiority trial

Study Record Dates

• First Submitted: July 20, 2022
• First Posted: August 3, 2022
• Study Start: November 17, 2022
• Primary Completion: February 8, 2024
• Study Completion: February 8, 2024
• Last Updated: May 7, 2025

Record last verified: 2025-05

Locations

CH (1)