General AnaesthesiaPhase 4NCT07673003
Sevoflurane Versus Propofol for Laryngeal Mask Airway Placement in Children Undergoing Surgery
A Phase 4 study testing propofol and Sevoflurane in people with General Anaesthesia and Airway Devices, run by Children's Hospital and Institute of Child Health, Multan at 1 site in Pakistan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- General Anaesthesia, Airway Devices, Airway Control
- What is being tested?
- propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jun 2025to 30 Nov 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- ASA physical status 1 and 2
- Undergoing elective minor surgical procedures below umbilicus
- Procedure lasting less than 60 min
Who cannot join
- Recent respiratory tract infection
- Bronchial asthma
- Family history of malignant hyperthermia
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Children's Hospital and Institute of Child Health Multan
Multan, Punjab Province, 60000
About this study
Official title: 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:
Read more
- 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.
- Conditions
- General Anaesthesia, Airway Devices, Airway Control
- Being tested
- propofol, Sevoflurane
- Keywords
- Sevoflurane, Propofol, Laryngeal Mask Airway, Pediatric Anesthesia, Jaw Relaxation, Elective Surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
propofolDrug
Intravenous propofol 3 mg/kg bolus will be administered for induction of general anesthesia before LMA insertion in pediatric patients.
SevofluraneDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Propofol Group | Active comparator | Children in this group will receive intravenous propofol as the induction agent for general anesthesia prior to laryngeal mask airway (LMA) insertion. Receives: Drug: propofol |
| Sevoflurane Group | Experimental | hildren in this group will receive inhalational sevoflurane for induction of general anesthesia prior to laryngeal mask airway (LMA) insertion. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Induction of Anesthesia
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.
Measured: From administration of the induction agent until loss of consciousness, assessed for up to 5 minutes after induction.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start1 Jun 2025
- Primary completion30 Nov 2025
- Study completion30 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for General AnaesthesiaStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital and Institute of Child Health, Multan
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Palwasha Sardar, Children's Hospital and Institute of Child Health, Multan
- Investigators
- Syed S Abbas, FCPS, Study chair, Children's Hospital and Institute of Child Health, Multan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673003
- Sponsor's protocol ID
- U1111-1342-4662
- Status last verified
- Jun 2026
- First submitted
- 17 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Sevoflurane and Propofol for Laryngeal Mask Airway Insertion in Children
- ClinicalTrials.gov ID
- NCT07673003
- Acronym / sponsor ID
- U1111-1342-4662
- Conditions
- General Anaesthesia, Airway Devices, Airway Control
- Keywords
- Sevoflurane, Propofol, Laryngeal Mask Airway, Pediatric Anesthesia, Jaw Relaxation, Elective Surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Children's Hospital and Institute of Child Health, MultanOther government
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 30 Nov 2025 (actual)
- Study completion
- 30 Nov 2025 (actual)
- First posted
- 29 Jun 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.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Propofol Group | Active comparator | Drug: propofolChildren in this group will receive intravenous propofol as the induction agent for general anesthesia prior to laryngeal mask airway (LMA) insertion. |
| Sevoflurane Group | Experimental | Drug: Sevofluranehildren in this group will receive inhalational sevoflurane for induction of general anesthesia prior to laryngeal mask airway (LMA) insertion. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- ASA physical status 1 and 2
- Undergoing elective minor surgical procedures below umbilicus
- Procedure lasting less than 60 min
Key exclusion criteria (3 listed)
- Recent respiratory tract infection
- Bronchial asthma
- Family history of malignant hyperthermia
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 |
|---|---|---|
| propofolIntravenous propofol 3 mg/kg bolus will be administered for induction of general anesthesia before LMA insertion in pediatric patients. | Drug | Propofol Group |
| SevofluraneSevoflurane 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. | Drug | Sevoflurane Group |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Syed S Abbas, FCPS study chair
Children's Hospital and Institute of Child Health, Multan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing propofol and Sevoflurane in people with General Anaesthesia and Airway Devices, run by Children's Hospital and Institute of Child Health, Multan at 1 site in Pakistan.
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 3 inclusion and 3 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: finished, as of the sponsor's last update on 29 Jun 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 Pakistan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). 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 29 Jun 2026.