Airway ManagementNCT07921602
Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
A study testing Tizanidine in people with Airway Management, run by Beni-Suef University at 1 site in Egypt.
Trial summary
This study will evaluate whether a single oral dose of tizanidine 4 mg given before surgery improves laryngeal mask airway (LMA) insertion conditions and postoperative recovery in adults undergoing elective ambulatory surgery under sevoflurane-based general anesthesia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Airway Management
- What is being tested?
- Tizanidine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- Nov 2026to May 2027
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years.
- ASA physical status I-II.
- Scheduled for elective ambulatory surgery (e.g., minor gynaecological, urological, general, or orthopaedic procedures) under general anesthesia using a standardized second-generation LMA (e.g., LMA Supreme or i-gel - one device type fixed for the entire trial).
- Expected surgical duration 30-120 minutes.
- Ability to understand the study and provide written informed consent. Exclusion Criteria
- ASA physical status III or higher.
Show all 21Show fewer
- Predicted difficult airway (Mallampati score III-IV, inter-incisor gap <3 cm, restricted neck mobility, or history of difficult airway).
- BMI >35 kg/m² (contraindication to supraglottic airway).
- Known or suspected gastro-oesophageal reflux disease, hiatal hernia, or other conditions increasing aspiration risk (contraindication to LMA).
- Known allergy or contraindication to tizanidine, alpha-2 adrenergic agonists, propofol, sevoflurane, or fentanyl.
- Significant cardiovascular disease: symptomatic arrhythmias, uncontrolled hypertension (SBP >160 mmHg despite treatment), second/third-degree heart block, or severe valvular disease.
- Baseline bradycardia (resting HR <50 beats/min) or hypotension (SBP <90 mmHg) on day of surgery.
- Significant hepatic impairment (Child-Pugh class B or C, or ALT/AST >3 × upper limit of normal), as tizanidine is a CYP1A2 hepatic substrate.
- Significant renal impairment (eGFR <30 mL/min/1.73 m²).
- Chronic use of centrally acting muscle relaxants, alpha-2 agonists, high-dose beta-blockers, or sedative/hypnotic agents.
- Concurrent use of strong CYP1A2 inhibitors (e.g., ciprofloxacin, fluvoxamine, enoxacin), which markedly increase tizanidine plasma concentrations [1].
- Current or recent chronic opioid use (daily opioid intake for >4 weeks prior to surgery).
- Active or treated obstructive sleep apnoea requiring home CPAP/BiPAP therapy.
- Pregnancy or breastfeeding.
- Current active smoker (>10 cigarettes/day) - to be recorded as a covariate if not excluded, but exclusion of heavy smokers minimizes airway reactivity confounding.
- Inability or refusal to provide informed consent.
Who cannot join
None listed.
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
Beni-Suef University Hospital
Banī Suwayf
Kerollos Moneer Neseem Mikhael
About this study
Official title: Single-Dose Oral Tizanidine Premedication for Laryngeal Mask Airway Insertion Conditions and Ambulatory Recovery Quality in Sevoflurane-Based Anesthesia: A Randomized Double-Blind Placebo-Controlled Trial
This study will evaluate whether a single oral dose of tizanidine 4 mg given before surgery improves laryngeal mask airway (LMA) insertion conditions and postoperative recovery in adults undergoing elective ambulatory surgery under sevoflurane-based general anesthesia.
Eligible adults aged 18 to 65 years with American Society of Anesthesiologists (ASA) physical status I or II will be randomly assigned to receive either oral tizanidine 4 mg or a matching placebo 60 to 90 minutes before anesthesia induction. Participants and the clinical and outcome-assessment teams will be blinded to treatment allocation.
Read more
The primary outcome is the proportion of participants with excellent LMA insertion conditions at the first insertion attempt, assessed using a predefined composite score. Secondary outcomes include anesthetic and opioid requirements, hemodynamic changes, emergence and recovery times, postoperative pain, quality of recovery, and adverse effects.
The study aims to determine whether tizanidine premedication improves airway insertion conditions and recovery outcomes without unacceptable adverse effects.
Read the detailed description
Tizanidine is a centrally acting alpha-2 adrenergic agonist with sedative, anxiolytic, muscle-relaxant, and sympatholytic properties. While alpha-2 agonists such as clonidine and dexmedetomidine reduce minimum alveolar concentration (MAC) requirements and facilitate airway management, their clinical utility in ambulatory surgery can be limited by prolonged sedation, bradycardia, or delayed discharge. Tizanidine offers a favorable pharmacological profile with a shorter half-life and potentially milder hemodynamic effects, yet evidence regarding its specific impact on supraglottic airway insertion and structured ambulatory recovery remains limited.
This prospective, randomized, double-blind, placebo-controlled trial evaluates the clinical efficacy of a single preoperative oral dose of tizanidine 4 mg compared with matching placebo in adult patients undergoing elective ambulatory surgery under standardized sevoflurane-based general anesthesia with a second-generation laryngeal mask airway (LMA).
Eligible participants are randomly assigned to receive either oral tizanidine 4 mg or an identical matching placebo capsule 60 to 90 minutes prior to anesthetic induction. All participants undergo a standardized general anesthetic protocol comprising IV fentanyl and propofol for induction, second-generation LMA insertion by experienced operators without neuromuscular blocking agents, and maintenance with end-tidal sevoflurane in oxygen/air.
The trial's primary objective is to determine whether preoperative tizanidine increases the proportion of patients achieving excellent LMA insertion conditions at the first attempt. Secondary objectives focus on evaluating induction propofol requirements, maintenance end-tidal sevoflurane concentrations, perioperative hemodynamic stability, emergence timelines, early and late recovery quality via the QoR-15 score, postoperative pain, opioid consumption, and treatment-emergent adverse events.
- Conditions
- Airway Management
- Being tested
- Tizanidine, Placebo
- Keywords
- Tizanidine, Laryngeal Mask Airway, Supraglottic Airway, General Anesthesia, Ambulatory Surgery, Postoperative Recovery, Quality of Recovery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TizanidineDrug
Also called Tizanidine Hydrochloride, Sirdalud
Single dose of oral tizanidine 4 mg (encapsulated in an opaque gelatin capsule), administered 60-90 minutes before induction of anesthesia with a small sip of water (< 30 mL).
PlaceboOther
Also called Matching Placebo
Single dose of matching oral placebo capsule, administered 60-90 minutes before induction of anesthesia with a small sip of water (< 30 mL).
| Study group | Role | What they receive |
|---|---|---|
| Tizanidine 4 mg | Active comparator | Participants receive a single preoperative oral dose of tizanidine 4 mg (encapsulated in an opaque gelatin capsule) with a small sip of water (< 30 mL) 60-90 minutes prior to induction of anesthesia. Receives: Drug: Tizanidine |
| Placebo Control | Placebo comparator | Participants receive a single preoperative oral matching placebo capsule with a small sip of water (< 30 mL) 60-90 minutes prior to induction of anesthesia. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Patients with Excellent Laryngeal Mask Airway (LMA) Insertion Conditions at First Attempt
Evaluated immediately after the first insertion attempt using a validated 5-domain composite scale (jaw relaxation, ease of insertion, patient movement, coughing/gagging, and laryngospasm/obstruction). Each domain is scored from 1 (optimal) to 3 (worst), yielding a total composite score range of 5 (optimal) to 15 (worst). 'Excellent' insertion condition is pre-specified as a total composite score of 5 to 7.
Measured: Immediately following the first LMA insertion attempt (approximately 1 to 3 minutes post-propofol induction)
Secondary outcomes (15)
Total Composite LMA Insertion Score
Composite evaluation of airway insertion conditions, measured by:
Continuous total composite LMA insertion score evaluated immediately after the first attempt across 5 domains (jaw relaxation, ease of insertion, patient movement, coughing/gagging, laryngospasm/obstruction; each domain scored 1 [optimal] to 3 [worst], total score range 5 [optimal] to 15 [worst]).
Measured: Immediately following the first LMA insertion attempt (approximately 1 to 3 minutes post-induction)
Time to Successful LMA Insertion
Elapsed time measured in seconds from the end of intravenous propofol injection to successful placement of the laryngeal mask airway with confirmed capnography waveform.
Measured: Intraoperative (during induction, up to 5 minutes)
Total Propofol Induction Requirement
Total weight-adjusted dose of intravenous propofol required to achieve loss of verbal response and eyelash reflex for LMA insertion, expressed in mg/kg.
Measured: Intraoperative (during induction of anesthesia, approximately 2-5 minutes)
Time-Weighted Average End-Tidal Sevoflurane Concentration
Mean time-weighted end-tidal concentration of sevoflurane (expressed as percentage / MAC fraction) recorded continuously from LMA placement until discontinuation of volatile agent at the end of surgery to evaluate the volatile anesthetic-sparing effect of premedication.
Measured: Intraoperative (from LMA insertion until end of surgery, approximately 30 to 120 minutes)
Incidence of Intraoperative Hypotension
Percentage of participants experiencing at least one episode of intraoperative hypotension, defined as systolic blood pressure < 90 mmHg or a > 20% decrease from baseline requiring intervention.
Measured: Baseline up to end of surgery (approximately 30 to 120 minutes)
Incidence of Intraoperative Bradycardia
Percentage of participants experiencing at least one episode of intraoperative bradycardia, defined as heart rate < 50 beats per minute or requiring intravenous atropine.
Measured: Baseline up to end of surgery (approximately 30 to 120 minutes)
Proportion of Participants Requiring Intraoperative Vasoactive Medications
Percentage of participants requiring administration of intraoperative vasoactive or anticholinergic drugs (ephedrine, phenylephrine, or atropine) for hemodynamic management.
Measured: Intraoperative (from premedication to end of surgery, approximately 30 to 120 minutes)
Time to Laryngeal Mask Airway Removal
Elapsed time in minutes from the discontinuation of sevoflurane to safe removal of the laryngeal mask airway upon return of protective airway reflexes and purposeful movement.
Measured: Postoperative emergence (from end of anesthesia up to 30 minutes)
Time to Achieve Readiness for Post-Anesthesia Care Unit Discharge
Elapsed time in minutes from arrival in the Post-Anesthesia Care Unit (PACU) to achieving a Modified Aldrete Score of 9 or higher (out of a total range of 0 to 10, where higher scores represent better recovery).
Measured: Postoperative PACU stay (up to 2 hours)
Postoperative Sedation Depth Assessed by Ramsay Sedation Scale Score
Level of postoperative sedation evaluated using the unabbreviated Ramsay Sedation Scale score. The score ranges from 1 (patient anxious, agitated, or restless) to 6 (patient asleep, no response to stimulus). A higher score indicates deeper sedation (worse alertness).
Measured: At 30 minutes postoperatively in the PACU
Postoperative Quality of Recovery Score (QoR-15) at 24 Hours
Patient-reported health status and recovery quality measured using the unabbreviated 15-item Quality of Recovery questionnaire (QoR-15). Total scores range from 0 to 150. A higher score indicates a better quality of recovery.
Measured: 24 hours postoperatively
Postoperative Pain Score on Numeric Rating Scale at PACU Arrival
Postoperative pain intensity assessed using the unabbreviated Numeric Rating Scale (NRS) for pain. The score ranges from 0 (no pain) to 10 (worst imaginable pain). A higher score indicates worse pain.
Measured: PACU arrival (0 minutes post-admission)
Cumulative Postoperative Opioid Consumption in PACU
Cumulative postoperative opioid analgesics administered during the PACU stay, converted to and expressed in oral morphine equivalents (OME, in milligrams).
Measured: From PACU arrival to PACU discharge (up to 2 hours)
Incidence of Postoperative Nausea and Vomiting
Percentage of participants experiencing at least one episode of postoperative nausea or vomiting during the PACU stay and first 24 hours postoperatively.
Measured: Up to 24 hours postoperatively
Incidence of Treatment-Emergent Adverse Effects
Percentage of participants experiencing tizanidine-related adverse effects (specifically dizziness, dry mouth, excessive somnolence, or headache) within the first 24 hours post-procedure.
Measured: Up to 24 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionMay 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Airway ManagementStudies of the same condition, open and under way.
- More trials run by Beni-Suef UniversityThe sponsor's other registered studies.
- 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
- Prospective, 1:1 randomized, parallel-group, double-blind, placebo-controlled trial.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beni-Suef University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kerollos Moneer Neseem Mikhael, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07921602
- Sponsor's protocol ID
- FMBSUREC/07062026c/ Mikhael
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the primary and secondary outcomes, baseline clinical characteristics, and statistical analysis code will be made available upon reasonable request from qualified academic researchers following peer-reviewed publication of the main trial results.
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single-Dose Oral Tizanidine Premedication for Laryngeal Mask Airway Insertion Conditions and Ambulatory Recovery Quality in Sevoflurane-Based Anesthesia: A Randomized Double-Blind Placebo-Controlled Trial
- ClinicalTrials.gov ID
- NCT07921602
- Acronym / sponsor ID
- FMBSUREC/07062026c/ Mikhael
- Conditions
- Airway Management
- Keywords
- Tizanidine, Laryngeal Mask Airway, Supraglottic Airway, General Anesthesia, Ambulatory Surgery, Postoperative Recovery, Quality of Recovery
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Beni-Suef UniversityUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Apr 2027 (estimated)
- Study completion
- May 2027 (estimated)
- First posted
- 6 Nov 2026 (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 evaluate whether a single oral dose of tizanidine 4 mg given before surgery improves laryngeal mask airway (LMA) insertion conditions and postoperative recovery in adults undergoing elective ambulatory surgery under sevoflurane-based general anesthesia.
Eligible adults aged 18 to 65 years with American Society of Anesthesiologists (ASA) physical status I or II will be randomly assigned to receive either oral tizanidine 4 mg or a matching placebo 60 to 90 minutes before anesthesia induction. Participants and the clinical and outcome-assessment teams will be blinded to treatment allocation.
The primary outcome is the proportion of participants with excellent LMA insertion conditions at the first insertion attempt, assessed using a predefined composite score. Secondary outcomes include anesthetic and opioid requirements, hemodynamic changes, emergence and recovery times, postoperative pain, quality of recovery, and adverse effects.
The study aims to determine whether tizanidine premedication improves airway insertion conditions and recovery outcomes without unacceptable adverse effects.
Detailed description
Tizanidine is a centrally acting alpha-2 adrenergic agonist with sedative, anxiolytic, muscle-relaxant, and sympatholytic properties. While alpha-2 agonists such as clonidine and dexmedetomidine reduce minimum alveolar concentration (MAC) requirements and facilitate airway management, their clinical utility in ambulatory surgery can be limited by prolonged sedation, bradycardia, or delayed discharge. Tizanidine offers a favorable pharmacological profile with a shorter half-life and potentially milder hemodynamic effects, yet evidence regarding its specific impact on supraglottic airway insertion and structured ambulatory recovery remains limited.
This prospective, randomized, double-blind, placebo-controlled trial evaluates the clinical efficacy of a single preoperative oral dose of tizanidine 4 mg compared with matching placebo in adult patients undergoing elective ambulatory surgery under standardized sevoflurane-based general anesthesia with a second-generation laryngeal mask airway (LMA).
Eligible participants are randomly assigned to receive either oral tizanidine 4 mg or an identical matching placebo capsule 60 to 90 minutes prior to anesthetic induction. All participants undergo a standardized general anesthetic protocol comprising IV fentanyl and propofol for induction, second-generation LMA insertion by experienced operators without neuromuscular blocking agents, and maintenance with end-tidal sevoflurane in oxygen/air.
The trial's primary objective is to determine whether preoperative tizanidine increases the proportion of patients achieving excellent LMA insertion conditions at the first attempt. Secondary objectives focus on evaluating induction propofol requirements, maintenance end-tidal sevoflurane concentrations, perioperative hemodynamic stability, emergence timelines, early and late recovery quality via the QoR-15 score, postoperative pain, opioid consumption, and treatment-emergent adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Prospective, 1:1 randomized, parallel-group, double-blind, placebo-controlled trial.
| Arm | Type | Receives |
|---|---|---|
| Tizanidine 4 mg | Active comparator | Drug: TizanidineParticipants receive a single preoperative oral dose of tizanidine 4 mg (encapsulated in an opaque gelatin capsule) with a small sip of water (< 30 mL) 60-90 minutes prior to induction of anesthesia. |
| Placebo Control | Placebo comparator | Other: PlaceboParticipants receive a single preoperative oral matching placebo capsule with a small sip of water (< 30 mL) 60-90 minutes prior to induction of anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age 18-65 years.
- ASA physical status I-II.
- Scheduled for elective ambulatory surgery (e.g., minor gynaecological, urological, general, or orthopaedic procedures) under general anesthesia using a standardized second-generation LMA (e.g., LMA Supreme or i-gel - one device type fixed for the entire trial).
- Expected surgical duration 30-120 minutes.
- Ability to understand the study and provide written informed consent. Exclusion Criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| TizanidineAlso: Tizanidine Hydrochloride, SirdaludSingle dose of oral tizanidine 4 mg (encapsulated in an opaque gelatin capsule), administered 60-90 minutes before induction of anesthesia with a small sip of water (< 30 mL). | Drug | Tizanidine 4 mg |
| PlaceboAlso: Matching PlaceboSingle dose of matching oral placebo capsule, administered 60-90 minutes before induction of anesthesia with a small sip of water (< 30 mL). | Other | Placebo Control |
Primary outcome
Proportion of Patients with Excellent Laryngeal Mask Airway (LMA) Insertion Conditions at First Attempt
Time frame: Immediately following the first LMA insertion attempt (approximately 1 to 3 minutes post-propofol induction)
Evaluated immediately after the first insertion attempt using a validated 5-domain composite scale (jaw relaxation, ease of insertion, patient movement, coughing/gagging, and laryngospasm/obstruction). Each domain is scored from 1 (optimal) to 3 (worst), yielding a total composite score range of 5 (optimal) to 15 (worst). 'Excellent' insertion condition is pre-specified as a total composite score of 5 to 7.
15 secondary outcomes
Total Composite LMA Insertion Score
Time frame: Immediately following the first LMA insertion attempt (approximately 1 to 3 minutes post-induction)
Time to Successful LMA Insertion
Time frame: Intraoperative (during induction, up to 5 minutes)
Total Propofol Induction Requirement
Time frame: Intraoperative (during induction of anesthesia, approximately 2-5 minutes)
Time-Weighted Average End-Tidal Sevoflurane Concentration
Time frame: Intraoperative (from LMA insertion until end of surgery, approximately 30 to 120 minutes)
Incidence of Intraoperative Hypotension
Time frame: Baseline up to end of surgery (approximately 30 to 120 minutes)
Incidence of Intraoperative Bradycardia
Time frame: Baseline up to end of surgery (approximately 30 to 120 minutes)
Proportion of Participants Requiring Intraoperative Vasoactive Medications
Time frame: Intraoperative (from premedication to end of surgery, approximately 30 to 120 minutes)
Time to Laryngeal Mask Airway Removal
Time frame: Postoperative emergence (from end of anesthesia up to 30 minutes)
Time to Achieve Readiness for Post-Anesthesia Care Unit Discharge
Time frame: Postoperative PACU stay (up to 2 hours)
Postoperative Sedation Depth Assessed by Ramsay Sedation Scale Score
Time frame: At 30 minutes postoperatively in the PACU
Postoperative Quality of Recovery Score (QoR-15) at 24 Hours
Time frame: 24 hours postoperatively
Postoperative Pain Score on Numeric Rating Scale at PACU Arrival
Time frame: PACU arrival (0 minutes post-admission)
Cumulative Postoperative Opioid Consumption in PACU
Time frame: From PACU arrival to PACU discharge (up to 2 hours)
Incidence of Postoperative Nausea and Vomiting
Time frame: Up to 24 hours postoperatively
Incidence of Treatment-Emergent Adverse Effects
Time frame: Up to 24 hours postoperatively
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 6 Nov 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the primary and secondary outcomes, baseline clinical characteristics, and statistical analysis code will be made available upon reasonable request from qualified academic researchers following peer-reviewed publication of the main trial results.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tizanidine in people with Airway Management, run by Beni-Suef 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 21 inclusion and 0 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: opening soon, as of the sponsor's last update on 6 Nov 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. Some participants in this study may receive a placebo. 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 Kerollos Moneer Neseem Mikhael, MD (00201288549959, Kmnmk87@med.bsu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of Patients with Excellent Laryngeal Mask Airway (LMA) Insertion Conditions at First Attempt (time frame: Immediately following the first LMA insertion attempt (approximately 1 to 3 minutes post-propofol induction)). 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 6 Nov 2026.