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

Sponsor
Children's Hospital of Fudan University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05769842
Collaborator
(none)
240
2
36

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
240 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Can Propofol Reduce Respiratory Adverse Events During Extubation in Children With Tonsillectomy? A Prospective Randomized Controlled Study
Anticipated Study Start Date :
Nov 1, 2023
Anticipated Primary Completion Date :
Nov 1, 2025
Anticipated Study Completion Date :
Nov 1, 2026

Arms and Interventions

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
  • Outcome Measures

    Primary Outcome Measures

    1. respiratory adverse events [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: laryngeal spasm: little or no airflow in jaw support,need mask pressure ventilation or anesthetic relief . bronchospasm:airway pressure increased, tidal volume decreased, and lung auscultation and wheezing were observed, accompanied by decreased oxygen saturation. breath-holding:no breathing time > 5 seconds or more. cough:0 = no cough; 1 point = weak cough; 2 points = strong cough; 3 points = continuous strong cough. low oxygen saturation:less than 92% on oxygen. respiratory obstruction:jaw support is needed for relief.

    Secondary Outcome Measures

    1. extubation time [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.

    2. Richmond Agitation Sedation Scale [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    3 Years to 8 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Children's Hospital of Fudan University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Children's Hospital of Fudan University
    ClinicalTrials.gov Identifier:
    NCT05769842
    Other Study ID Numbers:
    • 2022-01
    First Posted:
    Mar 15, 2023
    Last Update Posted:
    Mar 22, 2023
    Last Verified:
    Mar 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Children's Hospital of Fudan University
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 22, 2023