Small Doses Muscle Relaxant in General Anesthesia (relaxant)

Respiratory Benefits of Small Doses Muscle Relaxant in General Anesthesia

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.

Study Overview

• Status: Recruiting
• Conditions: Muscle Relaxant
• Intervention / Treatment: Drug: Atracurium Besylate regular dose; Drug: Atracurium Besylate minial dose

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.

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Maha Ahmed Abo-Zeid, MD; Phone Number: 02-01019216192; Email: mahazed@mans.edu.eg

Study Locations

• Egypt
  • Mansoura, Egypt
    • Recruiting
    • Mansoura University-Emergency hospital-ICU
    • Contact: Maha Ahmed Abo-Zeid, MD; Phone Number: 00201019216192; Email: Mahazed@mans.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Drug: 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
Experimental: 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.	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the first intraoperative need of muscle relaxant bolus (Atracurium), in the M group	blouse of muscle relaxant given only upon complain of the surgeon and after a bolus dose of propofol 0.5 mg/kg	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	a bolus dose of propofol 0.5 mg/kg given in the M group, upon complain of the surgeon and before boluses of muscle relaxant	intraoperatively
first Postoperative day complications	desaturation (Spo2 less than 90%), need for re-intubation, need of ventilation support	after removal of the tracheal tube and for 24 hours postoperative
lung aeration via Lung ultrasound dynamic re-aeration score	0= normal aeration (horizontal A-lines or ≤ 2 B-lines); 1 = moderate loss of aeration (multiple B-lines, either regularly spaced (7 mm apart), or irregularly spaced and even coalescent but only visible in a limited area of the intercostal space); 2 = loss of aeration (multiple coalescent B-lines, in prevalent areas of the intercostal spaces and observed in one or several intercostal spaces); 3 = complete loss of aeration (lung consolidation, with or without air bronchograms)	basal immmediate preoperative & with first 30 minutes postoperative

Collaborators and Investigators

• Sponsor: Mansoura University
• Investigators: Study Director: Maha Ahmed Abozeid, MD, Faculty of Medicine - Mansoura University

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2020
• Primary Completion (Estimated): December 30, 2025
• Study Completion (Estimated): June 30, 2026

Study Registration Dates

• First Submitted: April 8, 2020
• First Submitted That Met QC Criteria: April 10, 2020
• First Posted (Actual): April 14, 2020

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Muscle Hypotonia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Neuromuscular Agents; Nicotinic Antagonists; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Atracurium
• Other Study ID Numbers: respiratory effect

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No