NCT01995214

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.

Trial Health

55
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
500

participants targeted

Target at P75+ for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

November 13, 2013

Completed
13 days until next milestone

First Posted

Study publicly available on registry

November 26, 2013

Completed
5 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Last Updated

November 26, 2013

Status Verified

November 1, 2013

Enrollment Period

6 months

First QC Date

November 13, 2013

Last Update Submit

November 21, 2013

Conditions

General AnesthesiaGeriatric Patient

Keywords

Postoperative deliriumGeriatricGeneral anesthesiaPropofolSevoflurane

Outcome Measures

Primary Outcomes (1)

  • Postoperative delirium

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

    at 24 postoperative hours

Secondary Outcomes (6)

  • Length of postanesthesia care unit (PACU) stay

    up to 2 hours after PACU admitting

  • Hemodynamic parameters

    5min, 10min, 20min, 30min after induction, 5min, 10min, 20min, 30min after skin incision, 5min, 10min, 20min, 30min before incision closure

  • Incidence of postoperative nausea and vomiting

    24 postoperative hours

  • Quality of recovery determined by quality of recovery (QOR-40; maximum score 200) score

    1,2,3,7 postoperative days

  • Postoperative delirium

    2st, 3st, 7st postoperative days

  • +1 more secondary outcomes

Study Arms (2)

P

EXPERIMENTAL

Anesthesia maintenance with propofol+remifentanil

Drug: Propofol

S

EXPERIMENTAL

Anesthesia maintenance with sevoflurane+remifentanil

Drug: Sevoflurane

Interventions

PropofolDRUG

Anesthesia maintenance with propofol+remifentanil guided by Narcotrend index monitoring.

P
SevofluraneDRUG

Anesthesia maintenance with sevoflurane+remifentanil guided by Narcrotrend index monitoring.

S

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tongji Hospital

Wuhan, Hubei, 430030, China

RECRUITING

MeSH Terms

Conditions

Emergence Delirium

Interventions

PropofolSevoflurane

Condition Hierarchy (Ancestors)

DeliriumConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesPostoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and SymptomsNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

PhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsMethyl EthersEthersHydrocarbons, FluorinatedHydrocarbons, Halogenated

Study Officials

  • Yuke Tian, MD., PhD.

    Department of Anaesthesiology, Tongji Hospital of Tongji Medical College, Huazhong University of Science and Technology

    STUDY CHAIR

Central Study Contacts

Wei Mei, MD., PhD

CONTACT

00862783663173wmei@tjh.tjmu.edu.cn

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 13, 2013

First Posted

November 26, 2013

Study Start

June 1, 2013

Primary Completion

December 1, 2013

Last Updated

November 26, 2013

Record last verified: 2013-11

Locations

CN(1)