- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07673003
Sevoflurane Versus Propofol for Laryngeal Mask Airway Placement in Children Undergoing Surgery
Comparison of Sevoflurane and Propofol for Laryngeal Mask Airway Insertion in Children
The goal of this clinical trial is to compare two commonly used anesthetic medicines, sevoflurane and propofol, for inserting a laryngeal mask airway (LMA) in children undergoing minor elective surgery. A laryngeal mask airway is a device placed in the throat to help children breathe safely during anesthesia.
The main questions this study aims to answer are:
- Does sevoflurane produce a faster onset of anesthesia than propofol?
- Is there a difference between sevoflurane and propofol in the time required to achieve jaw relaxation for LMA insertion?
- Is there a difference between the two medicines in the time required for successful LMA insertion?
The researchers hypothesize that children receiving sevoflurane will have a shorter induction time than those receiving propofol.
A total of 170 children aged 4 to 12 years who are undergoing minor surgical procedures below the umbilicus will participate in the study. Participants will be randomly assigned to receive either intravenous propofol or inhaled sevoflurane for induction of anesthesia.
During the procedure, the anesthesia team will measure the time taken to lose consciousness, the time required to achieve adequate jaw relaxation, and the time needed for successful insertion of the laryngeal mask airway. These measurements will help determine which anesthetic agent provides better conditions for LMA insertion in children.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Punjab Province
-
Multan, Punjab Province, Pakistan, 60000
- Children's Hospital and Institute of Child Health Multan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- ASA physical status 1 and 2
- Undergoing elective minor surgical procedures below umbilicus
- Procedure lasting less than 60 min
Exclusion Criteria:
- Recent respiratory tract infection
- Bronchial asthma
- Family history of malignant hyperthermia
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Propofol Group
Children in this group will receive intravenous propofol as the induction agent for general anesthesia prior to laryngeal mask airway (LMA) insertion.
|
Intravenous propofol 3 mg/kg bolus will be administered for induction of general anesthesia before LMA insertion in pediatric patients.
|
|
Experimental: Sevoflurane Group
hildren in this group will receive inhalational sevoflurane for induction of general anesthesia prior to laryngeal mask airway (LMA) insertion.
|
Sevoflurane 7% will be delivered via inhalation in a nitrous oxide/oxygen mixture (2:1) for induction of general anesthesia prior to LMA insertion in pediatric patients.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Induction of Anesthesia
Time Frame: From administration of the induction agent until loss of consciousness, assessed for up to 5 minutes after induction.
|
Time (in seconds) measured from administration of the induction agent (propofol or sevoflurane) to loss of consciousness, defined as loss of verbal response and loss of eyelash reflex in pediatric patients undergoing elective surgery for laryngeal mask airway insertion.
|
From administration of the induction agent until loss of consciousness, assessed for up to 5 minutes after induction.
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Time to Jaw Relaxation
Time Frame: From administration of the induction agent until achievement of adequate jaw relaxation (mouth opening >4 cm), assessed for up to 5 minutes after induction.
|
Time (in seconds) measured from administration of induction agent to adequate jaw relaxation, defined as sufficient mouth opening (>4 cm) allowing insertion of laryngeal mask airway.
|
From administration of the induction agent until achievement of adequate jaw relaxation (mouth opening >4 cm), assessed for up to 5 minutes after induction.
|
|
Time to Laryngeal Mask Airway (LMA) Insertion
Time Frame: From administration of the induction agent until successful laryngeal mask airway insertion, assessed for up to 5 minutes after induction.
|
Time (in seconds) measured from administration of induction agent to successful insertion of laryngeal mask airway using standard technique.
|
From administration of the induction agent until successful laryngeal mask airway insertion, assessed for up to 5 minutes after induction.
|
Collaborators and Investigators
Investigators
- Study Chair: Syed S Abbas, FCPS, Children's Hospital and Institute of Child Health, Multan
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- U1111-1342-4662
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on General Anaesthesia
-
B. Braun Melsungen AGTigermed Consulting Co., Ltd; B. Braun Medical International Trading Company...CompletedGeneral Anaesthesia | Induction of AnaesthesiaChina
-
R-PharmSynergy Research Inc.CompletedGeneral AnaesthesiaRussian Federation
-
Universiti Sains MalaysiaAmbu A/SCompletedGeneral AnaesthesiaMalaysia
-
Oslo University HospitalThe Research Council of Norway; Danmeter (Denmark)Unknown
-
Jan JakobssonUniversity of California, IrvineTerminated
-
Zhang HaopengCompleted
-
University Hospital Schleswig-HolsteinCompleted
-
Centre Hospitalier Universitaire DijonCompletedOpioid Free Anaesthesia | Opioid AnaesthesiaFrance
-
Centre Hospitalier Universitaire DijonCompletedOpioid Free Anaesthesia | Opioid AnaesthesiaFrance
-
University Hospital Schleswig-HolsteinUnknown
Clinical Trials on propofol
-
Nurdan SağbaşActive, not recruitingMajor Depression | Bipolar Affective Disorder | Bipolar Depression Depressed PhaseTurkey (Türkiye)
-
Groupe Hospitalier Diaconesses Croix Saint-SimonCompletedOocyte Retrieval | Medically Assisted Procreation (MAP)France
-
Hacettepe UniversityRecruitingSedation | Target Controlled Infusion of Propofol | Intensive Care Unit SedationTurkey (Türkiye)
-
Karolinska InstitutetNot yet recruiting
-
Marmara University Pendik Training and Research...Not yet recruitingEndoscopic Submucosal Dissection | Respiratory Complications | Target Controlled Infusion of Propofol | Endoscopy Unit
-
Hopital FochCompleted
-
Stanford UniversityTiny Blue Dot FoundationEnrolling by invitationHealthy VolunteersUnited States
-
Istanbul University - CerrahpasaRecruitingAtrial Fibrillation | Deep Sedation | Electric CountershockTurkey (Türkiye)
-
University Medical Center GroningenCompletedAnesthesia | Hemodynamic Instability | Interaction | Disorder of Oxygen TransportNetherlands
-
Konkuk University Medical CenterCompletedCoronary Artery Disease | Valvular Heart DiseaseKorea, Republic of