Effects of Propofol on Respiratory Adverse Events During Extubation in Children Undergoing Tonsil Adenoidectomy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

239 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-01

Study Completion Date

2024-01-01

Brief Summary

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The main objective of this study was to investigate whether propofol assisted extubation could reduce the incidence of respiratory adverse events in children with tonsil adenoidectomy.

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Detailed Description

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In pediatric surgery, the incidence of perioperative respiratory adverse events in children undergoing tonsillectomy is higher than that of general surgery. Studies have shown that intravenous induction can reduce perioperative respiratory adverse events compared with inhalation induction. There are also literatures that show that intravenous anesthesia can significantly reduce cough and hemodynamic reactions during the wake period compared with balanced anesthesia.However, inhalation anesthesia is easier to use and can monitor the depth of anesthesia, so it is used more frequently than intravenous anesthesia.The incidence of respiratory adverse events has not been compared between intraoperative sevoflurane maintenance and extubation with a small amount of propofol versus total sevoflurane maintenance and extubation.The objective of this study was to investigate whether propofol can reduce perioperative adverse respiratory events in children undergoing tonsillectomy.

Conditions

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Airway Complication of Anesthesia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Pediatric patients were randomly assigned to either the propofol group or the control group. In the propofol group, after the child regained spontaneous breathing before extubation, propofol was administered in small repeated doses, each dose being 0.5mg/kg, with a total amount of 1\~2mg/kg. The control group received an equivalent volume of normal saline. The occurrence of respiratory adverse events (such as laryngospasm, bronchospasm, breath-holding, coughing, decreased oxygen saturation, and airway obstruction) was observed in both groups post-extubation, with the presence of any one or more events considered indicative of respiratory adverse events.

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Caregivers Outcome Assessors

Study Groups

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propofol group

Children aged 3 to 8 years who had had their tonsil adenoidectomy were collected. Propofol 3mg/kg, remifentanil 3-5ug /kg and atropine 0.01mg/kg were used for intravenous induction intubation. Sevoflurane was used for intraoperative anesthesia, propartamol 30mg/kg and hydromorphone 5-10ug /kg were used for postoperative analgesia.When sevoflurane was shut down at the end of the operation, oxygen flow was increased to more than 7L/min, and extubation was prepared for spontaneous respiration recovery, propofol was given a small amount of 1\~2mg/kg multiple times without inhibition of spontaneous respiration.

Group Type EXPERIMENTAL

propofol

Intervention Type DRUG

Propofol was mainly used in the intervention group during anesthesia extubation. Propofol was given a small amount of times about 1\~2mg/kg before extubation when the patient recovered spontaneously.

control group

Anesthesia induction is the same as before.At the end of the operation, sevoflurane was shut down and oxygen flow was increased to more than 7L/min. No other treatment was performed during extubation.

Group Type SHAM_COMPARATOR

normal saline

Intervention Type DRUG

Same dose as propofol.

Interventions

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propofol

Propofol was mainly used in the intervention group during anesthesia extubation. Propofol was given a small amount of times about 1\~2mg/kg before extubation when the patient recovered spontaneously.

Intervention Type DRUG

normal saline

Same dose as propofol.

Intervention Type DRUG

Other Intervention Names

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No Other Intervention Names No Other Intervention Names

Eligibility Criteria

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Inclusion Criteria

* age: 3\~8 years old,
* general anesthesia for tracheal intubation in ASA Grade I to III patients undergoing tonsil adenoidectomy,
* the operation time is 10\~60 minutes,
* sign informed consent.

Exclusion Criteria

* patients with congenital heart disease, tumor, severe lung disease, liver and kidney function disease, nervous system disease, coagulation dysfunction, etc,
* children who do not consent to the test.

Minimum Eligible Age

3 Years

Maximum Eligible Age

8 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No