Clinical trial NCT04344262: Small Doses Muscle Relaxant in General Anesthesia
Official title: Respiratory Benefits of Small Doses Muscle Relaxant in General Anesthesia
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Muscle Relaxant
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2020-04-14
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomly allocated via sealed opaque envelopes into 2 groups of 30 patients each; control (C) group and minimal dose (M) group
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The time to extubation in minutes
timeFrame: after injecting the muscle relaxant till removal of the tracheal tube
Secondary outcomes:
measure: Time to the first intraoperative need of muscle relaxant bolus (Atracurium), in the M group
timeFrame: Given intraoperatively only upon complain of the surgeon and after a bolus dose of propofol 0.5 mg/kg
measure: Total doses of propofol used in M group post-induction
timeFrame: intraoperatively
measure: first Postoperative day complications
timeFrame: after removal of the tracheal tube and for 24 hours postoperative
measure: lung aeration via Lung ultrasound dynamic re-aeration score
timeFrame: basal immmediate preoperative & with first 30 minutes postoperative
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Mansoura University-Emergency hospital-ICU
Study officials:
affiliation: Faculty of Medicine - Mansoura University
name: Maha Ahmed Abozeid, MD
role: STUDY_DIRECTOR
References: