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

NCT05769842 | Completed

• 1 other identifier: 2022-01
• Study Type: interventional
• Target: 239
• Locations: 1 country
• Sites: 1

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.

Conditions

Airway Complication of Anesthesia

Keywords

propofol; tracheal extubation; respiratory adverse events

Outcome Measures

Primary Outcomes (1)

• respiratory adverse events

  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 Outcomes (2)

• extubation time

  No more than three hours from the end of the procedure until the tracheal tube was pulled out.

• 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.

Study Arms (2)

propofol group

EXPERIMENTAL

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

control group

SHAM COMPARATOR

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

Interventions

propofol 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.

Also known as: No Other Intervention Names

propofol group

normal saline DRUG

Same dose as propofol.

Also known as: No Other Intervention Names

control group

Eligibility Criteria

• Age: 3 Years - 8 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Children's Hospital of Fudan University: lead

Study Sites (1)

Children's Hospital affiliated with Fudan University

Shanghai, 201102, China

Location

Related Publications (4)

• Ramgolam A, Hall GL, Zhang G, Hegarty M, von Ungern-Sternberg BS. Inhalational versus IV induction of anesthesia in children with a high risk of perioperative respiratory adverse events. Anesthesiology. 2018;128(6):1065-1074. AORN J. 2018 Nov;108(5):566-571. doi: 10.1002/aorn.12390. No abstract available.

  PMID: 30376178 BACKGROUND

• Hohlrieder M, Tiefenthaler W, Klaus H, Gabl M, Kavakebi P, Keller C, Benzer A. Effect of total intravenous anaesthesia and balanced anaesthesia on the frequency of coughing during emergence from the anaesthesia. Br J Anaesth. 2007 Oct;99(4):587-91. doi: 10.1093/bja/aem203. Epub 2007 Jul 27.

  PMID: 17660457 BACKGROUND

• von Ungern-Sternberg BS, Davies K, Hegarty M, Erb TO, Habre W. The effect of deep vs. awake extubation on respiratory complications in high-risk children undergoing adenotonsillectomy: a randomised controlled trial. Eur J Anaesthesiol. 2013 Sep;30(9):529-36. doi: 10.1097/EJA.0b013e32835df608.

  PMID: 23344124 BACKGROUND

• Liao R, Zhou Z, Wang X, Shao H. Impact of Propofol Administered before Extubation on Respiratory Adverse Events in Pediatric Patients Undergoing Tonsillectomy and Adenoidectomy: A Randomized Controlled Trial. Br J Hosp Med (Lond). 2024 Nov 30;85(11):1-15. doi: 10.12968/hmed.2024.0431. Epub 2024 Nov 18.

  PMID: 39618204 DERIVED

MeSH Terms

Interventions

Propofol; Saline Solution

Intervention Hierarchy (Ancestors)

Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Zhijian Zhou

  Children's Hospital of Fudan University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 2, 2023
• First Posted: March 15, 2023
• Study Start: November 1, 2023
• Primary Completion: December 30, 2023
• Study Completion: January 1, 2024
• Last Updated: February 5, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)