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

Primary Purpose

Emergence Agitation

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Extubation under deep anesthesia
Sponsored by
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Emergence Agitation

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Shanghai9 HospitalRecruiting
  • Shanghai ninth people's hospitalRecruiting
  • Shanghai No.9 People's HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Extubation under deep anesthesia

Awake extubation

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The incidence of Emergence Agitation during recovery
The incidence of Emergence Agitation during recovery

Secondary Outcome Measures

Full Information

First Posted
April 5, 2021
Last Updated
September 1, 2021
Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
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1. Study Identification

Unique Protocol Identification Number
NCT04844333
Brief Title
Effect of Extubation Under Deep Anesthesia on Emergence Agitation of Nasal Surgery
Official Title
Effect of Extubation Under Deep Anesthesia on Emergence Agitation of Nasal Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 8, 2021 (Actual)
Primary Completion Date
March 8, 2022 (Anticipated)
Study Completion Date
March 8, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Emergence Agitation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Extubation under deep anesthesia
Arm Type
Experimental
Arm Description
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.
Arm Title
Awake extubation
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Extubation under deep anesthesia
Intervention Description
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 Outcome Measure Information:
Title
The incidence of Emergence Agitation during recovery
Description
The incidence of Emergence Agitation during recovery
Time Frame
During recovery period after Nasal Surgery，an average of one and a half hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
jingjie Li, Ph.D
Phone
13801718306
Email
116212@sh9hospital.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
jingjie Li, Ph.D
Organizational Affiliation
Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shanghai9 Hospital
City
Shanghai
State/Province
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li JingJie, M.D.
Phone
18019790516
Email
116212@sh9hospital.org
Facility Name
Shanghai ninth people's hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Jingjie, Ph.D
Phone
13801718306
Email
116212@sh9hospital.org
First Name & Middle Initial & Last Name & Degree
Zhang Lei, Ph.D
Phone
18717822662
Facility Name
Shanghai No.9 People's Hospital
City
Shanghai
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jingjie Li, M.D
Phone
18019790516
Email
116212@sh9hospital.org

12. IPD Sharing Statement

Plan to Share IPD
No

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

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