Effects of Anesthetics on High-Dose Rocuronium

NCT ID: NCT06045559

Last Updated: 2024-03-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 75 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-10-02
• Study Completion Date: 2024-09-02

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.

Conditions

Neuromuscular Blockade; Anesthetic Agents

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

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 minimal alveolar concentration (MAC) value between 1-1.5.

No interventions assigned to this group

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.

No interventions assigned to this group

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.

No interventions assigned to this group

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mustafa Kemal University

OTHER

Sponsor Role: lead

Responsible Party

Selim Turhanoglu

Professor Dr.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Selim Turhanoglu, MD

Role: PRINCIPAL_INVESTIGATOR

Mustafa Kemal University

Serhat Hakkoymaz, MD

Role: STUDY_DIRECTOR

Mustafa Kemal University

Menekşe Okşar, MD

Role: STUDY_DIRECTOR

Mustafa Kemal University

Muhyittin Temiz, MD

Role: STUDY_DIRECTOR

Mustafa Kemal University

Emre Dirican

Role: STUDY_DIRECTOR

Mustafa Kemal University

Locations

Hatay Mustafa Kemal University

Antakya, Hatay, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

Selim Turhanoglu, MD

Role: CONTACT

adat63@gmail.com

+905325062988

Menekşe Okşar, MD

Role: CONTACT

menekseoksar@gmail.com

+905337108301

Facility Contacts

Selim Turhanoglu, MD

Role: primary

adat63@gmail.com

+905325062988

Other Identifiers

2022/38

Identifier Type: -

Identifier Source: org_study_id