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

February 1, 2024 updated by: Children's Hospital of Fudan University

Can Propofol Reduce Respiratory Adverse Events During Extubation in Children With Tonsillectomy? A Prospective Randomized Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

239

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Shanghai, China, 201102
        • Children's Hospital affiliated with Fudan University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 8 years (Child)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: 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.
Other Names:
  • No Other Intervention Names
Sham Comparator: 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.
Drug: normal saline
Same dose as propofol.
Other Names:
  • No Other Intervention Names

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
respiratory adverse events
Time Frame: From the moment of extubation to the time before entering the resuscitation room, the maximum time is no more than four hours.

These include six items in total:

  1. laryngeal spasm: little or no airflow in jaw support,need mask pressure ventilation or anesthetic relief .
  2. bronchospasm:airway pressure increased, tidal volume decreased, and lung auscultation and wheezing were observed, accompanied by decreased oxygen saturation.
  3. breath-holding:no breathing time > 5 seconds or more.
  4. cough:0 = no cough; 1 point = weak cough; 2 points = strong cough; 3 points = continuous strong cough.
  5. low oxygen saturation:less than 92% on oxygen.
  6. respiratory obstruction:jaw support is needed for relief.
From the moment of extubation to the time before entering the resuscitation room, the maximum time is no more than four hours.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
extubation time
Time Frame: No more than three hours from the end of the procedure until the tracheal tube was pulled out.
longer than 15 minutes means longer extubation time.
No more than three hours from the end of the procedure until the tracheal tube was pulled out.
Richmond Agitation Sedation Scale
Time Frame: From the moment of extubation to the time before entering the resuscitation room, the maximum time is no more than four hours.
The score ranges from -5 to +4. A higher score indicates more agitation and a lower score indicates greater calmness. In this study, a score greater than or equal to 1 indicates agitation.
From the moment of extubation to the time before entering the resuscitation room, the maximum time is no more than four hours.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Children's Hospital of Fudan University

Investigators

  • Study Director: Zhijian Zhou, Children's Hospital of Fudan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Actual)

December 30, 2023

Study Completion (Actual)

January 1, 2024

Study Registration Dates

First Submitted

February 2, 2023

First Submitted That Met QC Criteria

March 14, 2023

First Posted (Actual)

March 15, 2023

Study Record Updates

Last Update Posted (Estimated)

February 5, 2024

Last Update Submitted That Met QC Criteria

February 1, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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.

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