Clinical trial NCT06059248: Effect of Different Head Positions During Endotracheal Intubation on Postoperative Sore Throat
Official title: Effect of Different Head Positions During General Anesthesia Endotracheal Intubation on Postoperative Sore Throat
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endotracheal Intubation
General Anesthesia
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
First posted: 2023-09-28
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The goal of this \[ randomized clinical trial\] is to \[effect of different head positions on the incidence of postoperative sore throat \] in \[patients with endotracheal intubation \]. The main question it aims to answer is: the rate of postoperative sore throat will be reduced or not with the patients' head position changed during intubation.

Detailed description: Objective: To investigate the effect of tracheal intubation in different head positions on the incidence of pharyngeal pain 1, 6 and 24h after operation;Effect of tracheal intubation in different head positions on the incidence of hoarseness 1, 6 and 24h after operation

Eligibility criteria: Inclusion Criteria:

1. Patients undergoing endotracheal intubation abdominal or lower extremity surgery under general anesthesia
2. age 18\~65 years old,
3. ASA grade I or II

Exclusion Criteria:

1. patients with pre-existing sore throat or hoarseness before anesthesia;
2. patients with cervical spine disease;
3. patients with upper respiratory infection or a history of tracheostomy;
4. Mallampati score ≥ 3;
5. participation in other clinical trials within the past three months.

Primary outcomes:
measure: Rate of Participants with postoperative sore throat
timeFrame: 1, 6, 24 hours after tracheal catheter removal
Secondary outcomes:
measure: Rate of Participants with postoperative hoarseness
timeFrame: 1, 6, 24 hours after tracheal catheter removal
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: Nanjing First Hospital, Nanjing Medical University
name: Gu Jianping
role: STUDY_CHAIR
References:
citation: Kusunoki T, Sawai T, Komasawa N, Shimoyama Y, Minami T. Correlation between extraction force during tracheal intubation stylet removal and postoperative sore throat. J Clin Anesth. 2016 Sep;33:37-40. doi: 10.1016/j.jclinane.2015.12.024. Epub 2016 Apr 6.
citation: Park JJ, Huh H, Yoon SZ, Lim HJ, Go DY, Cho JE, Lee J, Park J, Kim HC. Two-handed jaw thrust decreases postoperative sore throat in patients undergoing double-lumen endobronchial intubation: A randomised study. Eur J Anaesthesiol. 2020 Feb;37(2):105-112. doi: 10.1097/EJA.0000000000001149.
citation: Seo JH, Cho CW, Hong DM, Jeon Y, Bahk JH. The effects of thermal softening of double-lumen endobronchial tubes on postoperative sore throat, hoarseness and vocal cord injuries: a prospective double-blind randomized trial. Br J Anaesth. 2016 Feb;116(2):282-8. doi: 10.1093/bja/aev414.