Small Doses Muscle Relaxant in General Anesthesia

NCT ID: NCT04344262

Last Updated: 2024-02-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-22
• Study Completion Date: 2026-06-30

Brief Summary

This study will be held to assess the effect of minimal dose muscle relaxant on postoperative pulmonary function. The time to extubation in minutes will be the primary outcome as a clinical indicator of the return of muscle power. The extubation time will be defined as the time from injecting the muscle relaxant reversing agent given when regain the train of four (TOF) ratio to 0.9 till removal of endotracheal tube.

Intraoperative surgical conditions will be assessed in the form of surgeon satisfaction and the need for more muscle relaxant boluses. Postoperative complications as desaturation (peripheral oxygen saturation (Spo2) less than 90%), the need for re-intubation or ventilation support will be recorded. Patient lung will be assessed using ultrasound-based lung aeration score. Also, the diaphragmatic and intercostal muscle function will be assessed in the early postoperative period. Immediate postoperative pulmonary function tests will be evaluated using simple spirometer. Patients will be followed up for 28 days for detection of pulmonary complications.

Detailed Description

After arrival to the operating theater, a thoracic US examination will be done using LUS dynamic re-aeration score. Patients will be randomly allocated via sealed opaque envelopes into 2 groups of 30 patients each; control (C) group and minimal dose (Min) group.

For general anesthesia; intubating dose of muscle relaxant will be injected according to the study group; in C group; atracurium 0.5 mg/kg while in min group 0.2 mg/kg will be injected. The trial for intubation will be assessed and recorded. Train-of-four (TOF) stimulation will be maintained less than 2 throughout the intraoperative period in the control group. While, in the min group, boluses of muscle relaxant will be given only upon complain of the surgeon and after a bolus dose of propofol 0.5 mg/kg. When required, 20% of the initial dose of muscle relaxant will be provided as a bolus to achieve this goal.

Conditions

Muscle Relaxant

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

control (C) group

Intubating dose of muscle relaxant will be atracurium 0.5 mg/kg

Maintenance doses of muscle relaxant will be given throughout the intraoperative period

to maintain the Train-of-four values continuously less than 2

Group Type: ACTIVE_COMPARATOR

Atracurium Besylate regular dose

Intervention Type: DRUG

Intubating dose of muscle relaxant will be atracurium 0.5 mg/kg

Maintenance doses of muscle relaxant will be given throughout the intraoperative period

to maintain the Train-of-four values continuously less than 2

minimal dose (M) group

Intubating dose of muscle relaxant will be 0.2 mg/kg will be injected

boluses of muscle relaxant will be given only upon complain of the surgeon and after a bolus dose of propofol 0.5 mg/kg. When required, 20% of the initial dose of muscle relaxant will be provided as a bolus to achieve this goal.

Group Type: EXPERIMENTAL

Atracurium Besylate minial dose

Intervention Type: DRUG

atracurium boluses of muscle relaxant given only upon complain of the surgeon and after a bolus dose of propofol 0.5 mg/kg. When required, 20% of the initial dose of muscle relaxant will be provided as a bolus to achieve this goal

Interventions

Atracurium Besylate regular dose

Intubating dose of muscle relaxant will be atracurium 0.5 mg/kg

Maintenance doses of muscle relaxant will be given throughout the intraoperative period

to maintain the Train-of-four values continuously less than 2

Intervention Type: DRUG

Atracurium Besylate minial dose

atracurium boluses of muscle relaxant given only upon complain of the surgeon and after a bolus dose of propofol 0.5 mg/kg. When required, 20% of the initial dose of muscle relaxant will be provided as a bolus to achieve this goal

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• adult patients
• aged from 20 to 50 years old
• scheduled for non-cardiothoracic surgery
• under general anesthesia
• in supine position
• after informed consent

Exclusion Criteria

• American Society of Anesthesiologists (ASA) score more than 3
• suspected full stomach or who will undergo intervention expected to necessitate profound muscle relaxation or dressing interferes with ultrasound (US) probe positioning
• Lung parenchymatous disease
• renal disease
• hepatic disease
• neuromuscular disease
• electrolytes imbalanc
• on medication interfere with muscle contraction
• with known allergy to any drug used in the study

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

maha abou-zeid

Lecturer of anesthesia and surgical intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maha Ahmed Abozeid, MD

Role: STUDY_DIRECTOR

Faculty of Medicine - Mansoura University

Locations

Mansoura University-Emergency hospital-ICU

Al Mansurah, , Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Maha Ahmed Abo-Zeid, MD

Role: CONTACT

mahazed@mans.edu.eg

02-01019216192

Facility Contacts

Maha Ahmed Abo-Zeid, MD

Role: primary

Mahazed@mans.edu.eg

00201019216192

Other Identifiers

respiratory effect

Identifier Type: -

Identifier Source: org_study_id