Official Title
Timing of Surgery in Pediatric Patients Following Fever Recovery: a Prospective Cohort Study
Brief Summary

Objectives: The timing of fever recovery may affect the risk of intra-operative hypoxemiain children undergoing elective surgery after SARS-CoV-2 infection. This study aims todetermine the optimal timing for surgery by analyzing the occurrence of intra-operativehypoxemia in pediatric patients after they have recovered from a fever.Methods: This prospective cohort study included 3053 children who had been infected withSARS-CoV-2 and developed fever, and scheduled to a surgery during March 2023 to August2023, children with temperature recovery time ≥3 month were compared to children withtemperature recovery time 0-8weeks. The primary outcome was measured as the incidence ofintra-operative hypoxemia in SARS-CoV-2 infected children after their body temperaturereturned to normal. Logistic regression models were used to calculate the adjustedincidence of hypoxemia rate sratified by time (0-2 weeks; 3-4 weeks; 5-6 weeks; 7-8weeks; ≥3 month) from body temperature recovery to the day of surgery.

Detailed Description

This prospective cohort study included 3053 pediatric patients who had been infected with
SARS-CoV-2 and developed fever, and scheduled to a surgery during March 2023 to August
2023.On the day of operation, the anesthesiologist in the children's operating room
conducted a preoperative evaluation. Upon confirming that general anesthesia was
appropriate, they proceeded to sign the informed consent for anesthesia. Three
anesthesiologists were assigned to the research group and conducted a second preoperative
visit to the children and their guardians in a separate room.

Body temperatures over 37.5 degrees Celsius was considered as fever. The time between
body temperature recovery and surgery was collected as categorical factor and was
scheduled to be analyzed in the following categories: 0-2 weeks; 3-4 weeks; 5-6 weeks;
7-8 weeks; And ≥ 3 months (control group). After entering the operating room, the
children were routinely monitored (pulse oxygen saturation-SpO2, blood pressure and
electrocardiogram). The anesthesia method and drug selection were decided by the
anesthesiologist in the operating room. The following data were collected and recorded:
age, height, weight and ASA classification; The preoperative medication and the
perioperative use of narcotic drugs ; The induction technique; The primary airway device;
The lowest value of SpO2 when the child entered the operating room, was intubated and was
extubated; PRAEs (such as cough, wheezing, laryngeal spasm and bronchial spasm) occurred
during operation; The treatment processwhen PRAEs occured; The total duration of
operation. The primary outcome was the incidence of intra-operative hypoxemia.

Completed
Fever

Other: Time interval between recovery of body temperature and operation

The time between body temperature recovery and surgery was collected as categorical
factor and was scheduled to be analyzed in the following categories: 0-2 weeks; 3-4
weeks; 5-6 weeks; 7-8 weeks; And ≥ 3 months (control group).

Eligibility Criteria

Inclusion Criteria:

1) Pediatric patients aged 1 to 18 years old; 2) American Society of Anesthesiologists
physical status (ASA) Ⅰ or Ⅱ; 3) Undergoing selective tonsillectomy, nasal and paranasal
sinus surgery, inguinal hernia repair, circumcision, internal fixation removal and other
elective or daytime operations in otolaryngology, general surgery or orthopedics.

Exclusion Criteria:

1) the weight is either less than or more than 15% of standard weight [standard weight
(kg) = height (cm) -100]; 2) body mass index (BMI) < 13.5 kg/m2 or > 31 kg/m2; 3)
presence of asthma or airway hyperresponsiveness, neuromuscular systemic disease or
cachexia, or difficult airway; 4) abnormal surgical anesthesia recovery history; 5)
operation duration > 2 hours; 6) participants in any drug clinical trial within 30 days
before the study; 7) absence of a definite date of fever recovery and other conditions
deemed unsuitable for inclusion by the researchers.

Eligibility Gender
All
Eligibility Age
Minimum: 1 Year ~ Maximum: 18 Years
Countries
China
Locations

The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
Wenzhou 1791388, Zhejiang 1784764, China

Lu Yi, physician, Principal Investigator
The Second Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University

Second Affiliated Hospital of Wenzhou Medical University
NCT Number
Keywords
Fever; SARS-CoV-2; Hypoxemia; Children
MeSH Terms
Fever
Hypoxia
Surgical Procedures, Operative