Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery
NCT07921602, Not applicable, Not yet recruiting, Beni-Suef University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Tizanidine Premedication Versus Placebo for Laryngeal Mask Airway Insertion and Recovery in Adults Undergoing Ambulatory Surgery | ClinicalTrials.gov |
| NCT number | NCT07921602 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Not applicable | ClinicalTrials.gov |
| Enrollment | 110 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Beni-Suef University | ClinicalTrials.gov |
| Conditions | Airway Management | ClinicalTrials.gov |
| Interventions | Tizanidine, Placebo | ClinicalTrials.gov |
| First posted | 2026-11-06 | ClinicalTrials.gov |
| Last updated | 2026-11-06 | ClinicalTrials.gov |
Registered outcomes 16
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Proportion of Patients with Excellent Laryngeal Mask Airway (LMA) Insertion Conditions at First Attempt | 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. | ClinicalTrials.gov |
| Secondary | Total Composite LMA Insertion Score | Immediately following the first LMA insertion attempt (approximately 1 to 3 minutes post-induction) | 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 \[worst\]). | ClinicalTrials.gov |
| Secondary | Time to Successful LMA Insertion | Intraoperative (during induction, up to 5 minutes) | Elapsed time measured in seconds from the end of intravenous propofol injection to successful placement of the laryngeal mask airway with confirmed capnography waveform. | ClinicalTrials.gov |
| Secondary | Total Propofol Induction Requirement | Intraoperative (during induction of anesthesia, approximately 2-5 minutes) | Total weight-adjusted dose of intravenous propofol required to achieve loss of verbal response and eyelash reflex for LMA insertion, expressed in mg/kg. | ClinicalTrials.gov |
| Secondary | Time-Weighted Average End-Tidal Sevoflurane Concentration | Intraoperative (from LMA insertion until end of surgery, approximately 30 to 120 minutes) | 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. | ClinicalTrials.gov |
| Secondary | Incidence of Intraoperative Hypotension | Baseline up to end of surgery (approximately 30 to 120 minutes) | 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. | ClinicalTrials.gov |
| Secondary | Incidence of Intraoperative Bradycardia | Baseline up to end of surgery (approximately 30 to 120 minutes) | Percentage of participants experiencing at least one episode of intraoperative bradycardia, defined as heart rate \< 50 beats per minute or requiring intravenous atropine. | ClinicalTrials.gov |
| Secondary | Proportion of Participants Requiring Intraoperative Vasoactive Medications | Intraoperative (from premedication to end of surgery, approximately 30 to 120 minutes) | Percentage of participants requiring administration of intraoperative vasoactive or anticholinergic drugs (ephedrine, phenylephrine, or atropine) for hemodynamic management. | ClinicalTrials.gov |
| Secondary | Time to Laryngeal Mask Airway Removal | Postoperative emergence (from end of anesthesia up to 30 minutes) | 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. | ClinicalTrials.gov |
| Secondary | Time to Achieve Readiness for Post-Anesthesia Care Unit Discharge | Postoperative PACU stay (up to 2 hours) | 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). | ClinicalTrials.gov |
| Secondary | Postoperative Sedation Depth Assessed by Ramsay Sedation Scale Score | At 30 minutes postoperatively in the PACU | 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). | ClinicalTrials.gov |
| Secondary | Postoperative Quality of Recovery Score (QoR-15) at 24 Hours | 24 hours postoperatively | 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. | ClinicalTrials.gov |
| Secondary | Postoperative Pain Score on Numeric Rating Scale at PACU Arrival | PACU arrival (0 minutes post-admission) | 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. | ClinicalTrials.gov |
| Secondary | Cumulative Postoperative Opioid Consumption in PACU | From PACU arrival to PACU discharge (up to 2 hours) | Cumulative postoperative opioid analgesics administered during the PACU stay, converted to and expressed in oral morphine equivalents (OME, in milligrams). | ClinicalTrials.gov |
| Secondary | Incidence of Postoperative Nausea and Vomiting | Up to 24 hours postoperatively | Percentage of participants experiencing at least one episode of postoperative nausea or vomiting during the PACU stay and first 24 hours postoperatively. | ClinicalTrials.gov |
| Secondary | Incidence of Treatment-Emergent Adverse Effects | Up to 24 hours postoperatively | Percentage of participants experiencing tizanidine-related adverse effects (specifically dizziness, dry mouth, excessive somnolence, or headache) within the first 24 hours post-procedure. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 0
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as | Source |
|---|
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)