Muscle Relaxant
Conditions
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.
Interventions
DRUGAtracurium 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
DRUGAtracurium 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
Sponsors
Mansoura University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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
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
Eligibility
Sex/Gender
ALL
Age
20 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The time to extubation in minutes | after injecting the muscle relaxant till removal of the tracheal tube | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | blouse of muscle relaxant given 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 | 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 |
| first Postoperative day complications | after removal of the tracheal tube and for 24 hours postoperative | desaturation (Spo2 less than 90%), need for re-intubation, need of ventilation support |
| lung aeration via Lung ultrasound dynamic re-aeration score | basal immmediate preoperative & with first 30 minutes postoperative | 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) |
Countries
Egypt
Contacts
Primary ContactMaha Ahmed Abo-Zeid, MD
Outcome results
None listed