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Postoperative Sleep Quality of Patients Anesthesia With Propofol or Sevoflurane Undergoing Thyroidectomy

NCT ID: NCT02146976

Last Updated: 2016-01-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-10-31

Study Completion Date

2015-10-31

Brief Summary

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The investigators designed a study to determine whether Propofol or Sevoflurane would provide same postoperative sleep quality in patients undergoing thyroidectomy.

Detailed Description

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The investigators designed a study to determine whether Propofol or Sevoflurane would provide same postoperative sleep quality in patients undergoing thyroidectomy.The bispectral index score (BIS) was monitored during the operation and the first postoperative night.

Conditions

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Postoperative Sleep Quality

Keywords

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postoperative sleep quality propofol sevoflurane

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Propofol

introvenious infusion of propofol

Group Type EXPERIMENTAL

propofol

Intervention Type DRUG

introvenious infusion of propofol

Inhaled anaesthetic (Sevoflurane)

sevoflurane (1.0-1.3% Minimum Alveolar Concentration)

Group Type EXPERIMENTAL

sevoflurane

Intervention Type DRUG

sevoflurane (1.0-1.3 Minimum Alveolar Concentration)

Interventions

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propofol

introvenious infusion of propofol

Intervention Type DRUG

sevoflurane

sevoflurane (1.0-1.3 Minimum Alveolar Concentration)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Participants were deemed eligible if they were candidates for general anesthesia undergoing thyroidectomy

Exclusion Criteria

* Patients were excluded if they had a body mass index exceeding 30 kg/m2, had a Pittsburgh Sleep Quality Index global scores higher than 6, had an anesthesia time longer than 4 hours, had a history of cardiovascular, neurological, or psychiatric disease, had cervical lymph node metastasis, were treated with sedative and analgesics during the postoperative BIS-Vista monitoring period, were allergic to drugs used in the study, or had been diagnosed with Graves' disease or hyperthyroidism or hypothyroidism.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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China Medical University, China

OTHER

Sponsor Role lead

Responsible Party

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Wen-fei Tan

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hong Ma, M.D.,Ph.D.

Role: STUDY_CHAIR

the Anesthesiology Department

Locations

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the First Hospital of China Medical University

Shenyang, Liaoning, China

Site Status

Countries

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China

Other Identifiers

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20140522

Identifier Type: -

Identifier Source: org_study_id