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Sevoflurane and Propofol Anesthesia on Postoperative Delirium

Primary Purpose

General Anesthesia, Geriatric Patient

Status
Unknown status
Phase
Phase 4
Locations
China
Study Type
Interventional
Intervention
Propofol
Sevoflurane
Sponsored by
Huazhong University of Science and Technology
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for General Anesthesia focused on measuring Postoperative delirium, Geriatric, General anesthesia, Propofol, Sevoflurane

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • American Society of Anesthesiologists Physical Status classification (ASA_PS) class I-III
  • Aged 60 years or above
  • Elective major surgery under general anesthesia

Exclusion Criteria:

  • ASA_PS>=IV
  • Aged under 60 yr old
  • Body mass index (BMI) >30
  • Neurologic disease
  • Cardiac surgery and neurologic surgery
  • Anticonvulsant drugs
  • Chronic analgesics intake
  • Participating in the investigation of another study

Sites / Locations

  • Tongji HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

P

S

Arm Description

Anesthesia maintenance with propofol+remifentanil

Anesthesia maintenance with sevoflurane+remifentanil

Outcomes

Primary Outcome Measures

Postoperative delirium
Postoperative delirium was determined by Confusion Assessment Method (CAM) at 24 postoperative hours

Secondary Outcome Measures

Length of postanesthesia care unit (PACU) stay
Length of PACU stay (min)
Hemodynamic parameters
Hart frequency, systolic blood pressure, diastolic blood pressure
Incidence of postoperative nausea and vomiting
Incidence of postoperative nausea and vomiting
Quality of recovery determined by quality of recovery (QOR-40; maximum score 200) score
Quality of recovery determined by QOR-40
Postoperative delirium
Postoperative delirium was determined by CAM every day at 2st, 3st, 7st postoperative days
Postoperative Stroke
Postoperative Stroke will be determined by National Institutes of Health Stroke Scale (NIHSS)

Full Information

First Posted
November 13, 2013
Last Updated
November 21, 2013
Sponsor
Huazhong University of Science and Technology
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1. Study Identification

Unique Protocol Identification Number
NCT01995214
Brief Title
Sevoflurane and Propofol Anesthesia on Postoperative Delirium
Official Title
Comparison of Sevoflurane and Propofol Anesthesia on Postoperative Delirium in Geriatric Patients
Study Type
Interventional

2. Study Status

Record Verification Date
November 2013
Overall Recruitment Status
Unknown status
Study Start Date
June 2013 (undefined)
Primary Completion Date
December 2013 (Anticipated)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Huazhong University of Science and Technology

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Delirium is defined as an acute onset and fluctuating course of mental status change with inattention and an altered level of consciousness. Delirium in the postoperative period can be divided into emergence delirium and postoperative delirium, based on the time of onset (Silverstein et al., 2007).Postanaesthesia delirium is a frequent and potentially serious problem affecting the safety of patients and medical personnel. Clinical studies demonstrated that postoperative delirium is associated with worse outcomes such as prolonged hospital stay, postdischarge institutionalization, and increased mortality (Ely et al., 2004a; Thomason et al., 2005; Robinson et al., 2009). Multiple factors may contribute to the development of postoperative delirium, including patient's medical condition, administration of anesthetics or analgesics and degree of operative stress (Yildizeli et al., 2005; Robinson & Eiseman, 2008; Deiner & Silverstein, 2009). Sevoflurane anesthesia have been reported to be associated with more emergence delirium in pediatric patients, when compared with propofol anesthesia. It is not clear if propofol anesthesia will benefit the geriatric patients on postoperative delirium, when compared with sevoflurane anesthesia. We hypothesize that propofol anesthesia will reduce the rate of postoperative delirium by 50% when compared with sevoflurane anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
General Anesthesia, Geriatric Patient
Keywords
Postoperative delirium, Geriatric, General anesthesia, Propofol, Sevoflurane

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
500 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
P
Arm Type
Experimental
Arm Description
Anesthesia maintenance with propofol+remifentanil
Arm Title
S
Arm Type
Experimental
Arm Description
Anesthesia maintenance with sevoflurane+remifentanil
Intervention Type
Drug
Intervention Name(s)
Propofol
Intervention Description
Anesthesia maintenance with propofol+remifentanil guided by Narcotrend index monitoring.
Intervention Type
Drug
Intervention Name(s)
Sevoflurane
Intervention Description
Anesthesia maintenance with sevoflurane+remifentanil guided by Narcrotrend index monitoring.
Primary Outcome Measure Information:
Title
Postoperative delirium
Description
Postoperative delirium was determined by Confusion Assessment Method (CAM) at 24 postoperative hours
Time Frame
at 24 postoperative hours
Secondary Outcome Measure Information:
Title
Length of postanesthesia care unit (PACU) stay
Description
Length of PACU stay (min)
Time Frame
up to 2 hours after PACU admitting
Title
Hemodynamic parameters
Description
Hart frequency, systolic blood pressure, diastolic blood pressure
Time Frame
5min, 10min, 20min, 30min after induction, 5min, 10min, 20min, 30min after skin incision, 5min, 10min, 20min, 30min before incision closure
Title
Incidence of postoperative nausea and vomiting
Description
Incidence of postoperative nausea and vomiting
Time Frame
24 postoperative hours
Title
Quality of recovery determined by quality of recovery (QOR-40; maximum score 200) score
Description
Quality of recovery determined by QOR-40
Time Frame
1,2,3,7 postoperative days
Title
Postoperative delirium
Description
Postoperative delirium was determined by CAM every day at 2st, 3st, 7st postoperative days
Time Frame
2st, 3st, 7st postoperative days
Title
Postoperative Stroke
Description
Postoperative Stroke will be determined by National Institutes of Health Stroke Scale (NIHSS)
Time Frame
1st, 2st, 3st, 7st postoperative days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: American Society of Anesthesiologists Physical Status classification (ASA_PS) class I-III Aged 60 years or above Elective major surgery under general anesthesia Exclusion Criteria: ASA_PS>=IV Aged under 60 yr old Body mass index (BMI) >30 Neurologic disease Cardiac surgery and neurologic surgery Anticonvulsant drugs Chronic analgesics intake Participating in the investigation of another study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Mei, MD., PhD
Phone
00862783663173
Email
wmei@tjh.tjmu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yuke Tian, MD., PhD.
Organizational Affiliation
Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology
Official's Role
Study Chair
Facility Information:
Facility Name
Tongji Hospital
City
Wuhan
State/Province
Hubei
ZIP/Postal Code
430030
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Mei, MD., PhD.
Phone
00862783663173
Email
wmei@tjh.tjmu.edu.cn

12. IPD Sharing Statement

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Sevoflurane and Propofol Anesthesia on Postoperative Delirium

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