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

NCT ID: NCT04844333

Last Updated: 2023-11-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-08
• Study Completion Date: 2022-04-02

Brief Summary

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.

Detailed Description

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.

Conditions

Emergence Agitation

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Extubation under deep anesthesia

When the patient is in sedation or anesthesia state, including 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 endotracheal tube is removed.

Group Type: EXPERIMENTAL

Extubation under deep anesthesia

Intervention Type: 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.

Awake extubation

When the patient is in awake state, including bispectral index \>70, spontaneous breathing recovery, VT ≥ 5ml / kg, respiratory rate 10-20 times / min, regular rhythm, PetCO2 \< 45mmhg, regular waveform, the cough and swallowing reflex are obvious and the circulation is stable, the endotracheal tube is removed.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Extubation under deep anesthesia

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Jingjie Li

Chief physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

jingjie Li, Ph.D

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Shanghai9 Hospital

Shanghai, Shanghai Municipality, China

Shanghai ninth people's hospital

Shanghai, , China

Shanghai No.9 People's Hospital

Shanghai, , China

Countries

China

References

Suo L, Lu L, Li J, Qiu L, Liu J, Shi J, Sun Z, Lao W, Zhou X. The effect of deep and awake extubation on emergence agitation after nasal surgery: a randomized controlled trial. BMC Anesthesiol. 2024 May 18;24(1):177. doi: 10.1186/s12871-024-02565-y.

Reference Type: DERIVED

PMID: 38762729 (View on PubMed)

Other Identifiers

SH9H-2020-T414-2

Identifier Type: -

Identifier Source: org_study_id