Effects of Anesthetics on High-Dose Rocuronium

Sponsor
Mustafa Kemal University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT06045559
Collaborator
(none)
75
11

Study Details

Study Description

Brief Summary

This study evaluates the effects of three different anesthetics on high dose rocuronium in laparoscopic cholecystectomy cases. Patients were randomly assigned to one of the propofol, desflurane, or sevoflurane groups.TOF and BIS monitoring were used during surgery in all groups.Patients were followed until TOF and PTC values reached 1 and the time was recorded.The effect of three anesthetic drugs used on the duration of the muscle relaxant drug was investigated.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    In recent years, studies have been published showing that by applying deep neuromuscular block during laparoscopic cholecystectomy, intra-abdominal pressure can be reduced without compromising the surgical conditions, thus complications such as postoperative pain, nausea and vomiting can be reduced.

    The results we obtained in our previous study showed that deep neuromuscular block achieved with a high dose of 1.2 mg/kg rocuronium allowed the operation to be performed with lower intra-abdominal pressure values, shortened the operation time, reduced PONV and pain in laparoscopic cholecystectomy cases. The most important factor affecting the depth of neuromuscular block is the dose of the neuromuscular agent.However, anesthetic agents can also affect the depth of neuromuscular blockade. The effects of muscle relaxants are enhanced when administered together with inhalation anesthetics.Propofol and sevoflurane are widely used in the maintenance of anesthesia. Unlike propofol, sevoflurane enhances the effects of some neuromuscular blocking drugs, including rocuronium.

    Our primary aim in this study is to evaluate the effects of sevoflurane, desflurane, or propofol, which are commonly used in anesthesia maintenance, on the duration of neuromuscular block caused by 1.2 mg/kg rocuronium, which is the dose we routinely use in anesthesia induction, in laparoscopic cholecystectomy cases. Secondary aims are to investigate its effects on intrabadominal pressures and surgical conditions, and to determine whether it reduces postoperative pain and PONV, as well as extubation and recovery times.

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    75 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Effects of Sevoflurane, Desflurane or Propofol Anesthesia on High-Dose Rocuronium in Laparoscopic Cholecystectomy Operations
    Anticipated Study Start Date :
    Oct 2, 2023
    Anticipated Primary Completion Date :
    Jun 28, 2024
    Anticipated Study Completion Date :
    Sep 2, 2024

    Arms and Interventions

    Arm Intervention/Treatment
    S(Sevoflurane)

    Anesthesia induction for all patients will be performed with 2 mg/kg propofol and 2 µg/kg fentanyl. Following loss of eyelash reflex, 1.2 mg/kg rocuronium will be administered intravenously to all patients. Anesthesia will be maintained with sevoflurane, with a BIS value between 40-50 and a MAC value between 1-1.5.

    D(Desflurane)

    Anesthesia induction for all patients will be performed with 2 mg/kg propofol and 2 µg/kg fentanyl. Following loss of eyelash reflex, 1.2 mg/kg rocuronium will be administered intravenously to all patients. Anesthesia will be maintained with desflurane, with a BIS value between 40-50 and a MAC value between 1-1.5.

    P(Propofol)

    Anesthesia induction for all patients will be performed with 2 mg/kg propofol and 2 µg/kg fentanyl. Following loss of eyelash reflex, 1.2 mg/kg rocuronium will be administered intravenously to all patients. Propofol was administered intravenously at a rate of 6-12 mg/kg/min to maintain anesthesia, keeping the BIS value between 40-50.

    Outcome Measures

    Primary Outcome Measures

    1. Duration of neuromuscular block with rocuronium. [15 seconds for TOF rates, 8 minutes for PTC values]

      TOF rates will be measured every 15 seconds and PTC values will be measured every 8 minutes. Additionally, the times of TOF 0 and PTC 0 responses and TOF1 and PTC 1 responses will be recorded.

    Secondary Outcome Measures

    1. intra-abdominal pressure [5 minutes]

      Effect of deep neuromuscular block on intra-abdominal pressure

    2. surgical conditions [It will be evaluated once at the end of the surgery based on the surgeon's satisfaction.]

      Effect of deep neuromuscular block on surgical conditions

    3. postoperative pain [2nd, 24th and 72nd hours after surgery]

      Effect of deep neuromuscular block on postoperative pain

    4. postoperative nausea and vomiting [postoperative 4th, 12th and 24th hours]

      The effect of deep neuromuscular blockade on postoperative nausea and vomiting will be evaluated.

    5. Length of extubation process [15sc]

      Time from discontinuation of maintenance anesthesia to extubation.

    6. Lenght of recovery process [1 mınute]

      Time from extubation to modified Aldrete score of 9.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • ASA Ⅰ-Ⅲ patients

    • between the ages of 18-65

    Exclusion Criteria:
    • Being under 18 of age or over 65

    • disapproval of the informed consent

    • rocuronium allergy

    • sugammadex allergy

    • pregnancy

    • lactation

    • hepatic or renal dysfunction

    • obesity (BMI≥35kg/m2)

    • Previous abdominal surgery

    • long-term use of NSAIs

    • neuromuscular disorders

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Mustafa Kemal University

    Investigators

    • Principal Investigator: Selim Turhanoglu, MD, Mustafa Kemal University
    • Study Director: Serhat Hakkoymaz, MD, Mustafa Kemal University
    • Study Director: Menekşe Okşar, MD, Mustafa Kemal University
    • Study Director: Muhyittin Temiz, MD, Mustafa Kemal University
    • Study Director: Emre Dirican, Mustafa Kemal University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Selim Turhanoglu, Professor Dr., Mustafa Kemal University
    ClinicalTrials.gov Identifier:
    NCT06045559
    Other Study ID Numbers:
    • 2022/38
    First Posted:
    Sep 21, 2023
    Last Update Posted:
    Sep 21, 2023
    Last Verified:
    Sep 1, 2023
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Selim Turhanoglu, Professor Dr., Mustafa Kemal University

    Study Results

    No Results Posted as of Sep 21, 2023