Small Doses Muscle Relaxant in General Anesthesia

NCT04344262 | Recruiting

• 1 other identifier: respiratory effect
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Muscle Relaxant

Outcome Measures

Primary Outcomes (1)

• The time to extubation in minutes

  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

  after injecting the muscle relaxant till removal of the tracheal tube

Secondary Outcomes (4)

• Time to the first intraoperative need of muscle relaxant bolus (Atracurium), in the M group

  Given intraoperatively only upon complain of the surgeon and after a bolus dose of propofol 0.5 mg/kg

• Total doses of propofol used in M group post-induction

  intraoperatively

• first Postoperative day complications

  after removal of the tracheal tube and for 24 hours postoperative

• lung aeration via Lung ultrasound dynamic re-aeration score

  basal immmediate preoperative & with first 30 minutes postoperative

Study Arms (2)

control (C) group

ACTIVE COMPARATOR

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

Drug: Atracurium Besylate regular dose

minimal dose (M) group

EXPERIMENTAL

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.

Drug: Atracurium Besylate minial dose

Interventions

Atracurium Besylate regular dose 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

control (C) group

Atracurium Besylate minial dose 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

minimal dose (M) group

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Mansoura University-Emergency hospital-ICU

Al Mansurah, Egypt

RECRUITING

MeSH Terms

Conditions

Muscle Hypotonia

Condition Hierarchy (Ancestors)

Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Maha Ahmed Abozeid, MD

  Faculty of Medicine - Mansoura University

  STUDY DIRECTOR

Central Study Contacts

Maha Ahmed Abo-Zeid, MD

CONTACT

02-01019216192; mahazed@mans.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Basal US assessment and its repetition in the recovery room, will be done by an anesthetist who is not involved in randomization or anesthetic technique except, after ending the surgery and after dressing, he will be responsible for reversal agent injection and the extubation with recording the extubation time
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of anesthesia and surgical intensive care

Model Details: Patients will be randomly allocated via sealed opaque envelopes into 2 groups of 30 patients each; control (C) group and minimal dose (M) group

Study Record Dates

• First Submitted: April 8, 2020
• First Posted: April 14, 2020
• Study Start: April 22, 2020
• Primary Completion: December 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 6, 2024

Record last verified: 2024-02

Locations

EG (1)