Small Doses Muscle Relaxant in General Anesthesia (relaxant)
Primary Purpose
Muscle Relaxant
Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Atracurium Besylate regular dose
Atracurium Besylate minial dose
Sponsored by
About this trial
This is an interventional treatment trial for Muscle Relaxant
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
Sites / Locations
- Mansoura University-Emergency hospital-ICURecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
control (C) group
minimal dose (M) group
Arm Description
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
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.
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
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
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
first Postoperative day complications
desaturation (Spo2 less than 90%), need for re-intubation, need of ventilation support
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)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04344262
Brief Title
Small Doses Muscle Relaxant in General Anesthesia
Acronym
relaxant
Official Title
Respiratory Benefits of Small Doses Muscle Relaxant in General Anesthesia
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 22, 2020 (Actual)
Primary Completion Date
July 30, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Muscle Relaxant
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Masking
ParticipantInvestigator
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
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
control (C) group
Arm Type
Active Comparator
Arm Description
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
Arm Title
minimal dose (M) group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Atracurium Besylate regular dose
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Atracurium Besylate minial dose
Intervention Description
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
Primary Outcome Measure Information:
Title
The time to extubation in minutes
Description
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
Time Frame
after injecting the muscle relaxant till removal of the tracheal tube
Secondary Outcome Measure Information:
Title
Time to the first intraoperative need of muscle relaxant bolus (Atracurium), in the M group
Description
blouse of muscle relaxant given only upon complain of the surgeon and after a bolus dose of propofol 0.5 mg/kg
Time Frame
Given intraoperatively only upon complain of the surgeon and after a bolus dose of propofol 0.5 mg/kg
Title
Total doses of propofol used in M group post-induction
Description
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
Time Frame
intraoperatively
Title
first Postoperative day complications
Description
desaturation (Spo2 less than 90%), need for re-intubation, need of ventilation support
Time Frame
after removal of the tracheal tube and for 24 hours postoperative
Title
lung aeration via Lung ultrasound dynamic re-aeration score
Description
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)
Time Frame
basal immmediate preoperative & with first 30 minutes postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maha Ahmed Abo-Zeid, MD
Phone
02-01019216192
Email
mahazed@mans.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maha Ahmed Abozeid, MD
Organizational Affiliation
Faculty of Medicine - Mansoura University
Official's Role
Study Director
Facility Information:
Facility Name
Mansoura University-Emergency hospital-ICU
City
Mansoura
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maha Ahmed Abo-Zeid, MD
Phone
00201019216192
Email
Mahazed@mans.edu.eg
12. IPD Sharing Statement
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Small Doses Muscle Relaxant in General Anesthesia
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