Muscle RelaxantrelaxantNCT04344262
Small Doses Muscle Relaxant in General Anesthesia
A study testing Atracurium Besylate regular dose and Atracurium Besylate minial dose in people with Muscle Relaxant, run by Mansoura University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Muscle Relaxant
- What is being tested?
- Atracurium Besylate regular dose and Atracurium Besylate minial dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 22 Apr 2020to 30 Jun 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- adult patients
- aged from 20 to 50 years old
- scheduled for non-cardiothoracic surgery
- under general anesthesia
- in supine position
- after informed consent
Who cannot join
- 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
Show all 9Show fewer
- electrolytes imbalanc
- on medication interfere with muscle contraction
- with known allergy to any drug used in the study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura University-Emergency hospital-ICU
Al Mansurah
Maha Ahmed Abo-Zeid, MD, 00201019216192, Mahazed@mans.edu.eg
About this study
Official title: 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.
Read the 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.
- Conditions
- Muscle Relaxant
- Being tested
- Atracurium Besylate regular dose, Atracurium Besylate minial dose
- Medical subject headings
- Muscle Hypotonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Atracurium Besylate regular doseDrug
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 doseDrug
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
| Study group | Role | What they receive |
|---|---|---|
| control (C) group | Active comparator | 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 Receives: Drug: Atracurium Besylate regular dose |
| minimal dose (M) group | Experimental | 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. Receives: Drug: Atracurium Besylate minial dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: after injecting the muscle relaxant till removal of the tracheal tube
Secondary outcomes (4)
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
Measured: 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
Measured: intraoperatively
first Postoperative day complications
desaturation (Spo2 less than 90%), need for re-intubation, need of ventilation support
Measured: 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)
Measured: basal immmediate preoperative & with first 30 minutes postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2020
- Study start22 Apr 2020
- Primary completion30 Dec 2029 (estimated)
- Study completion30 Jun 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle RelaxantStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, maha abou-zeid, Mansoura University
- Investigators
- Maha Ahmed Abozeid, MD, Study director, Faculty of Medicine - Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04344262
- Sponsor's protocol ID
- respiratory effect
- Acronym
- relaxant
- Status last verified
- Oct 2026
- First submitted
- 8 Apr 2020
- Last updated
- 15 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Respiratory Benefits of Small Doses Muscle Relaxant in General Anesthesia
- ClinicalTrials.gov ID
- NCT04344262
- Acronym / sponsor ID
- relaxant / respiratory effect
- Conditions
- Muscle Relaxant
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 30 Dec 2029 (estimated)
- Study completion
- 30 Jun 2030 (estimated)
- First posted
- 14 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- 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
| Arm | Type | Receives |
|---|---|---|
| control (C) group | Active comparator | Drug: Atracurium Besylate regular doseIntubating 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 |
| minimal dose (M) group | Experimental | Drug: Atracurium Besylate minial doseIntubating 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. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- adult patients
- aged from 20 to 50 years old
- scheduled for non-cardiothoracic surgery
- under general anesthesia
- in supine position
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Atracurium Besylate regular doseIntubating 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 | control (C) group |
| Atracurium Besylate minial doseatracurium 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 | Drug | minimal dose (M) group |
Primary outcome
The time to extubation in minutes
Time frame: 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
4 secondary outcomes
Time to the first intraoperative need of muscle relaxant bolus (Atracurium), in the M group
Time frame: 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
Time frame: intraoperatively
first Postoperative day complications
Time frame: after removal of the tracheal tube and for 24 hours postoperative
lung aeration via Lung ultrasound dynamic re-aeration score
Time frame: basal immmediate preoperative & with first 30 minutes postoperative
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Maha Ahmed Abozeid, MD study director
Faculty of Medicine - Mansoura University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atracurium Besylate regular dose and Atracurium Besylate minial dose in people with Muscle Relaxant, run by Mansoura University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maha Ahmed Abo-Zeid, MD (02-01019216192, mahazed@mans.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The time to extubation in minutes (time frame: after injecting the muscle relaxant till removal of the tracheal tube). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2026.