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

January 28, 2016 updated by: Wen-fei Tan, China Medical University, China
The investigators designed a study to determine whether Propofol or Sevoflurane would provide same postoperative sleep quality in patients undergoing thyroidectomy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

124

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Liaoning
      • Shenyang, Liaoning, China, 110001
        • The First Hospital of China Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Propofol
introvenious infusion of propofol
Drug: propofol
introvenious infusion of propofol
Experimental: Inhaled anaesthetic (Sevoflurane)
sevoflurane (1.0-1.3% Minimum Alveolar Concentration)
Drug: sevoflurane
sevoflurane (1.0-1.3 Minimum Alveolar Concentration)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change of postoperative sleep quality
Time Frame: preoperation, first postoperative night
The primary outcome was the postoperative sleep quality, which was measured by the BIS-Vista monitor on the first night after surgery.
preoperation, first postoperative night

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

China Medical University, China

Investigators

  • Study Chair: Hong Ma, M.D.,Ph.D., the Anesthesiology Department

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2014

Primary Completion (Actual)

September 1, 2015

Study Completion (Actual)

October 1, 2015

Study Registration Dates

First Submitted

May 22, 2014

First Submitted That Met QC Criteria

May 23, 2014

First Posted (Estimate)

May 26, 2014

Study Record Updates

Last Update Posted (Estimate)

January 29, 2016

Last Update Submitted That Met QC Criteria

January 28, 2016

Last Verified

November 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20140522

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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