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Completed

NCT Number: NCT06059248

Effect of Different Head Positions During Endotracheal Intubation on Postoperative Sore Throat

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.

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Key information

Conditions

Endotracheal Intubation General Anesthesia

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing First Hospital

Nanjing, Jiangsu, 210006, China

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patients undergoing endotracheal intubation abdominal or lower extremity surgery under general anesthesia
  • age 18~65 years old,
  • ASA grade I or II

Exclusion criteria

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

Treatment and study plan

the head in the "sniffing position "

Other

Intubation was performed with the head in the " elevation " position

Primary outcomes

  1. Rate of Participants with postoperative sore throat

    Time frame: 1, 6, 24 hours after tracheal catheter removal

    Postoperative sore throat is defined as: persistent sore throat with the following grades: 1 point: no sore throat; 2 points: mild, accompanied by odynophagia; 3 points: moderate pain, persistent, worsening with swallowing; 4 points: severe, pain interferes with eating, requires the use of pain medication

Secondary outcomes

  1. Rate of Participants with postoperative hoarseness

    Time frame: 1, 6, 24 hours after tracheal catheter removal

    Hoarseness is defined as a sound quality different from the preoperative voice and is graded as follows: 1 point: none, no hoarseness; 2 points: slight hoarseness, noticed by the patient; 3 points: moderate hoarseness, pronounced to observer; 4 points: severe hoarseness, loss of voice.

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Registry information

Official study title

Effect of Different Head Positions During General Anesthesia Endotracheal Intubation on Postoperative Sore Throat

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Sep 28, 2023
Registry last updated
Nov 15, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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