Small Doses Muscle Relaxant in General Anesthesia

Muscle Relaxant Clinical Trial

— relaxant  

Official title:

Respiratory Benefits of Small Doses Muscle Relaxant in General Anesthesia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04344262
• Other study ID #: respiratory effect
• Status: Recruiting
• Phase: N/A
• Start date: April 22, 2020
• Est. completion date: June 30, 2026

Study information

• Verified date: February 2024
• Source: Mansoura University
• Contact: Maha Ahmed Abo-Zeid, MD
• Phone: 02-01019216192
• Email: mahazed[@]mans.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: June 30, 2026
• Est. primary completion date: December 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 50 Years

Eligibility

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

Related Conditions & MeSH terms

• Muscle Hypotonia
• Muscle Relaxant

Intervention

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
• 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

Locations

Country	Name	City	State
Egypt	Mansoura University-Emergency hospital-ICU	Mansoura

Sponsors (1)

Lead Sponsor	Collaborator
Mansoura University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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