An interventional study of Tizanidine and Placebo in Airway Management, sponsored by Beni-Suef University. Not yet recruiting at 1 site in Egypt. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-06.
Sponsored by Beni-Suef University · Not applicable, Interventional, and Treatment
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.
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.
Beni-Suef University is the lead sponsor of 349 studies on the registry; 125 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Tizanidine
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.
Other: Placebo
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).
Also known as: Tizanidine Hydrochloride, Sirdalud
Single dose of matching oral placebo capsule, administered 60-90 minutes before induction of anesthesia with a small sip of water (\< 30 mL).
Also known as: Matching Placebo
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.
Time frame: Immediately following the first LMA insertion attempt (approximately 1 to 3 minutes post-propofol induction)
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 \[worst\]).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: Up to 24 hours postoperatively
Plan to share: 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.
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will become available starting 6 months following publication of the primary manuscript and will remain accessible for up to 3 years.
Access criteria: Access will be granted to researchers providing a methodologically sound research proposal that aims to achieve the objectives outlined in the approved proposal. Requests should be directed to the Principal Investigator (Dr. Kerollos Moneer Neseem Mikhael). A data use agreement may be required.
No publications or documents are linked to this record.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tizanidine