Clinical trial NCT06045559: Effects of Anesthetics on High-Dose Rocuronium
Official title: Effects of Sevoflurane, Desflurane or Propofol Anesthesia on High-Dose Rocuronium in Laparoscopic Cholecystectomy Operations
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Neuromuscular Blockade
Anesthetic Agents
Keywords: inhalational anesthetics
Neuromuscular Blockade
rocuronium
Lead sponsor: Mustafa Kemal University
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients between the ages of 18 and 65 who applied to our hospital for laparoscopic cholecystectomy surgery from October 2023 to June 2024.

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. Train of four (TOF) and bispectral index (BIS) monitoring were used during surgery in all groups.Patients were followed until TOF and post tetanic count (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.

Detailed description: In recent years, studies have been published showing that by applying deep neuromuscular block during laparoscopic cholecystectomy, intraabdominal pressure can be reduced without compromising the surgical conditions, thus complications such as postoperative nausea and vomiting (PONV) and pain 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 intraabdominal pressures and surgical conditions, and to determine whether it reduces postoperative pain and PONV, as well as extubation and recovery times.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiology (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

Primary outcomes:
measure: Duration of neuromuscular block with rocuronium.
timeFrame: 15 seconds for TOF rates, 8 minutes for PTC values
Secondary outcomes:
measure: intra-abdominal pressure
timeFrame: 5 minutes
measure: surgical conditions
timeFrame: It will be evaluated once at the end of the surgery based on the surgeon's satisfaction.
measure: postoperative pain
timeFrame: 2nd, 24th and 72nd hours after surgery
measure: postoperative nausea and vomiting
timeFrame: postoperative 4th, 12th and 24th hours
measure: Length of extubation process
timeFrame: 15sc
measure: Lenght of recovery process
timeFrame: 1 mınute
Other outcomes:
Locations:
city: Antakya
country: Turkey
facility: Hatay Mustafa Kemal University
state: Hatay
Study officials:
affiliation: Mustafa Kemal University
name: Selim Turhanoglu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mustafa Kemal University
name: Serhat Hakkoymaz, MD
role: STUDY_DIRECTOR
affiliation: Mustafa Kemal University
name: Menekşe Okşar, MD
role: STUDY_DIRECTOR
affiliation: Mustafa Kemal University
name: Muhyittin Temiz, MD
role: STUDY_DIRECTOR
affiliation: Mustafa Kemal University
name: Emre Dirican
role: STUDY_DIRECTOR
References: