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NCT Number: NCT04844333

Effect of Extubation Under Deep Anesthesia on Emergence Agitation of Nasal Surgery

This study analyzed the relationship between extubation timing and Emergence agitation in 18-60 years old adults undergoing nasal surgery, such as nasal septum correction, endoscopic sinus surgery, and nasal bone fracture reduction. The number of agitation, sedation score, pain score, operation method, analgesic drugs and other data were recorded to analyze the effect of deep anesthesia extubation on agitation in patients with nasal surgery. It also provides a clinical basis for the prevention and treatment of agitation during the recovery period of such operations in adults.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Shanghai9 Hospital, Shanghai, Shanghai Municipality, China

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About this study

Nasal surgery is an operation with a high proportion of pain and agitation found in the clinical medical treatment of our hospital. Although the operation time is short, the operation trauma is small, and it does not involve important organs and blood vessels, the clinical observation shows that the incidence of agitation in such patients after operation is high, and the degree of pain varies greatly. Many studies have analyzed the related risk factors of agitation in the wake-up period of adult nasal surgery, and believe that the existence of postoperative endotracheal tube is the main risk factor. However, there is a lack of prospective randomized controlled study on the timing of postoperative extubation in patients with nasal surgery. Therefore, this study analyzes the impact of extubation timing on postoperative agitation, so as to clarify the correlation between postoperative agitation and extubation timing and possible protective factors, which is helpful to early prediction, prevention and treatment, and reduce the incidence of postoperative EA in patients with nasal surgery.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

ASA grade I-II Age 18-60 Patients undergoing selective general anesthesia for the correction of septum, endoscopic sinus surgery, bone fracture reconstruction, resection of sinus tumor, augmentation of nose and other nasal surgery Subjects voluntarily participate in the study and sign informed consent

Exclusion criteria

History of mental and neurological diseases; History of chronic pain or long-term use of opioids and other analgesics; History of respiratory diseases, severe pulmonary dysfunction and airway hyperresponsiveness; History of severe hypertension and cardiovascular disease; Pregnant women; Patients with severe primary diseases such as liver, kidney and hematopoietic system; patients with abnormal liver function (ALT, AST and TBIL exceeding 1.5 times the upper limit of normal value) or renal dysfunction (creatinine and urea nitrogen exceeding 1.5 times the upper limit of normal value) History of alcohol or drug abuse; History of epilepsy or a recent epilepsy; Obese patients, BMI ≥ 30kg / m2, or with sleep apnea; In addition to the above, the researchers judged that they were not suitable to participate in this clinical trial.

Treatment and study plan

Extubation under deep anesthesia

Other

When the patient in sedation or anesthesia state, no body movement, bispectral index 60-70, spontaneous breathing recovery, VT ≥ 5ml / kg, respiratory rate 10-20 times / min, regular rhythm, PetCO2 < 45mmhg, regular waveform, stable circulation, the patient is in deep anesthesia state, and the endotracheal tube is removed.

Primary outcomes

  1. The incidence of Emergence Agitation during recovery

    Time frame: During recovery period after Nasal Surgery,an average of one and a half hours

    The incidence of Emergence Agitation during recovery

Sponsors and collaborators

Lead sponsor

Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Apr 14, 2021
Registry last updated
Nov 29, 2023

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

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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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