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

NCT04844333 | Completed

• 1 other identifier: SH9H-2020-T414-2
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 3

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.

Conditions

Emergence Agitation

Outcome Measures

Primary Outcomes (1)

• The incidence of Emergence Agitation during recovery

  The incidence of Emergence Agitation during recovery

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

Study Arms (2)

Extubation under deep anesthesia

EXPERIMENTAL

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.

Other: Extubation under deep anesthesia

Awake extubation

NO INTERVENTION

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.

Interventions

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.

Extubation under deep anesthesia

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: lead

Study Sites (3)

Shanghai9 Hospital

Shanghai, Shanghai Municipality, China

Location

Shanghai ninth people's hospital

Shanghai, China

Location

Shanghai No.9 People's Hospital

Shanghai, China

Location

Related Publications (1)

• 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.

  PMID: 38762729 DERIVED

MeSH Terms

Conditions

Emergence Delirium

Condition Hierarchy (Ancestors)

Delirium; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• jingjie Li, Ph.D

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: April 5, 2021
• First Posted: April 14, 2021
• Study Start: May 8, 2021
• Primary Completion: March 30, 2022
• Study Completion: April 2, 2022
• Last Updated: November 29, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)