Effects of Anesthetics on High-Dose Rocuronium

Neuromuscular Blockade Clinical Trial

Official title:

Effects of Sevoflurane, Desflurane or Propofol Anesthesia on High-Dose Rocuronium in Laparoscopic Cholecystectomy Operations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06045559
• Other study ID #: 2022/38
• Status: Recruiting
• Start date: October 2, 2023
• Est. completion date: September 2, 2024

Study information

• Verified date: March 2024
• Source: Mustafa Kemal University
• Contact: Selim Turhanoglu, MD
• Phone: +905325062988
• Email: adat63[@]gmail.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: September 2, 2024
• Est. primary completion date: June 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiology (ASA) ?-? 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

Related Conditions & MeSH terms

• Neuromuscular Blockade

Locations

Country	Name	City	State
Turkey	Hatay Mustafa Kemal University	Antakya	Hatay

Sponsors (1)

Lead Sponsor	Collaborator
Mustafa Kemal University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of neuromuscular block with rocuronium.	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.	15 seconds for TOF rates, 8 minutes for PTC values
Secondary	intra-abdominal pressure	Effect of deep neuromuscular block on intra-abdominal pressure	5 minutes
Secondary	surgical conditions	Effect of deep neuromuscular block on surgical conditions	It will be evaluated once at the end of the surgery based on the surgeon's satisfaction.
Secondary	postoperative pain	Effect of deep neuromuscular block on postoperative pain	2nd, 24th and 72nd hours after surgery
Secondary	postoperative nausea and vomiting	The effect of deep neuromuscular blockade on postoperative nausea and vomiting will be evaluated.	postoperative 4th, 12th and 24th hours
Secondary	Length of extubation process	Time from discontinuation of maintenance anesthesia to extubation.	15sc
Secondary	Lenght of recovery process	Time from extubation to modified Aldrete score of 9.	1 minute