Interaction of Sevoflurane Propofol and Remifentanil in Anesthesia for Laparoscopic Surgery

NCT02457442 | Completed Phase 4

• 2 other identifiers: SPRV157/15
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

Brief Summary

Recently a new model for the interaction of sevoflurane propofol and remifentanil was developed. The potency of any combination of the three drugs is defined as probability that a subject tolerates laryngoscopy without movement response. The model allows to compare the potency of intravenous and inhalation anesthetics. If the model is valid also for other stimuli than laryngoscopy and for other responses (e.g. blood pressure or heart rate increase upon stimulation). If the model is valid equipotent concentrations of sevoflurane and propofol the same remifentanil concentration would be sufficient to suppress hemodynamic response to a given stimulus. This will be investigated it the study.

Conditions

Drug Interactions; Anesthesia, Conduction

Keywords

Anesthetics, Inhalation; Anesthetics, Intravenous; Analgesics, Opioid

Outcome Measures

Primary Outcomes (1)

• 20% heart rate or mean arterial pressure increase upon installation of pneumoperitoneum

  5 Minutes upon establishment of intraabdominal working pressure (12 mmHg)

Secondary Outcomes (4)

• Mean (SD) Bloodpressure during surgery

  Values recorded on computer HD every 10 sec during anesthesia, expected to be on average ca. 60 - 240 minutes

• Mean (SD) Bispectral Index during surgery

  Values recorded on computer HD every 10 sec. during anesthesia, expected to be on average ca. 60 - 240 minutes

• Mean (SD) Remifentanil concentration during surgery

  During surgery, expected to be on average ca. 60 - 240 minutes

• Postoperative quality of recovery score

  During hospital stay, expected to be on average ca. 3-5 days

Study Arms (6)

PR1

ACTIVE COMPARATOR

(Arm closed in May 2022) Propofol-Remifentanil: Prop high, Remi low. Changing Remi (up-and-down)

Drug: Propofol and Remifentanil

PR2

ACTIVE COMPARATOR

(Arm closed in May 2022) Propofol-Remifentanil: Prop low, Remi high. Changing Prop (up-and-down)

Drug: Propofol and Remifentanil

SR1

ACTIVE COMPARATOR

(Arm closed in May 2022) Sevoflurane-Remifentanil: Sevo high, Remi low. Changing Remi (up-and-down)

Drug: Sevoflurane and Remifentanil

SR2

ACTIVE COMPARATOR

(Arm closed in May 2022) Sevoflurane-Remifentanil: Sevo low, Remi high. Changing Sevo (up-and-down)

Drug: Sevoflurane and Remifentanil

SPR1

ACTIVE COMPARATOR

(Arm closed in October 2023) Sevoflurane-Propofol-Remifentanil: Sevo plus Remi intermediate, Remi intermediate; changing Propofol.

Drug: SPR 1

SPR2

ACTIVE COMPARATOR

(Arm closed in October 2023) Sevoflurane-Propofol-Remifentanil: Sevo plus Remi intermediate, Remi intermediate; changing Sevoflurane.

Drug: SPR2

Interventions

Propofol and Remifentanil DRUG

High propofol and low remifentanil, changing remifentanil (up-and-down method)

PR1

Sevoflurane and Remifentanil DRUG

High sevoflurane and low remifentanil, changing remifentanil (up-and-down method)

SR1

SPR 1 DRUG

Triple combination with intermediate propofol and sevoflurane and intermediate remifentanil. SPR 1: Changing Propofol for skin incision.

SPR1

SPR2 DRUG

Triple combination with intermediate propofol and sevoflurane and intermediate remifentanil. Changing Sevoflurane for skin incision.

SPR2

Eligibility Criteria

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

You may qualify if:

• ASA physical status 1 or 2
• Written informed consent

You may not qualify if:

• Cardiovascular disease
• Pulmonary disease
• Liver disease
• CNS disease
• Alcohol or drug abuse
• Chronic intake of CNS active drugs
• Body mass index \> 35
• Diabetes mellitus
• Hypersensitivity or allergy to one of the study drugs

Sponsors & Collaborators

• Insel Gruppe AG, University Hospital Bern: lead

Study Sites (1)

Department of Anesthesiology and Pain Therapy, Bern University Hospital

Bern, 3010, Switzerland

Location

Related Publications (5)

• Schumacher PM, Dossche J, Mortier EP, Luginbuehl M, Bouillon TW, Struys MM. Response surface modeling of the interaction between propofol and sevoflurane. Anesthesiology. 2009 Oct;111(4):790-804. doi: 10.1097/ALN.0b013e3181b799ef.

  PMID: 19741484 BACKGROUND

• Heyse B, Proost JH, Schumacher PM, Bouillon TW, Vereecke HE, Eleveld DJ, Luginbuhl M, Struys MM. Sevoflurane remifentanil interaction: comparison of different response surface models. Anesthesiology. 2012 Feb;116(2):311-23. doi: 10.1097/ALN.0b013e318242a2ec.

  PMID: 22222473 BACKGROUND

• Luginbuhl M, Schumacher PM, Vuilleumier P, Vereecke H, Heyse B, Bouillon TW, Struys MM. Noxious stimulation response index: a novel anesthetic state index based on hypnotic-opioid interaction. Anesthesiology. 2010 Apr;112(4):872-80. doi: 10.1097/ALN.0b013e3181d40368.

  PMID: 20216387 BACKGROUND

• Bouillon TW, Bruhn J, Radulescu L, Andresen C, Shafer TJ, Cohane C, Shafer SL. Pharmacodynamic interaction between propofol and remifentanil regarding hypnosis, tolerance of laryngoscopy, bispectral index, and electroencephalographic approximate entropy. Anesthesiology. 2004 Jun;100(6):1353-72. doi: 10.1097/00000542-200406000-00006.

  PMID: 15166553 BACKGROUND

• Hannivoort LN, Vereecke HE, Proost JH, Heyse BE, Eleveld DJ, Bouillon TW, Struys MM, Luginbuhl M. Probability to tolerate laryngoscopy and noxious stimulation response index as general indicators of the anaesthetic potency of sevoflurane, propofol, and remifentanil. Br J Anaesth. 2016 May;116(5):624-31. doi: 10.1093/bja/aew060.

  PMID: 27106965 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration

Interventions

Propofol; Remifentanil; Sevoflurane

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Propionates; Acids, Acyclic; Carboxylic Acids; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Methyl Ethers; Ethers; Hydrocarbons, Fluorinated; Hydrocarbons, Halogenated

Study Officials

• Martin Luginbühl, PD Dr. med.

  Spital Tiefenau, Inselgruppe, Abteilung für Anästhesie und Intensivmedizin

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 26, 2015
• First Posted: May 29, 2015
• Study Start: December 1, 2015
• Primary Completion: October 23, 2023
• Study Completion: October 23, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

CH (1)