Postoperative Sleep Quality of Patients Anesthesia With Propofol or Sevoflurane Undergoing Thyroidectomy
1 other identifier
interventional
124
1 country
1
Brief Summary
The investigators designed a study to determine whether Propofol or Sevoflurane would provide same postoperative sleep quality in patients undergoing thyroidectomy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Oct 2014
Shorter than P25 for phase_4
1 active site
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
First Submitted
Initial submission to the registry
May 22, 2014
CompletedFirst Posted
Study publicly available on registry
May 26, 2014
CompletedStudy Start
First participant enrolled
October 1, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2015
CompletedJanuary 29, 2016
November 1, 2015
11 months
May 22, 2014
January 28, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
The Change of postoperative sleep quality
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
Study Arms (2)
Propofol
EXPERIMENTALintrovenious infusion of propofol
Inhaled anaesthetic (Sevoflurane)
EXPERIMENTALsevoflurane (1.0-1.3% Minimum Alveolar Concentration)
Interventions
sevoflurane (1.0-1.3 Minimum Alveolar Concentration)
Eligibility Criteria
You may qualify if:
- Participants were deemed eligible if they were candidates for general anesthesia undergoing thyroidectomy
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
the First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Hong Ma, M.D.,Ph.D.
the Anesthesiology Department
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
May 22, 2014
First Posted
May 26, 2014
Study Start
October 1, 2014
Primary Completion
September 1, 2015
Study Completion
October 1, 2015
Last Updated
January 29, 2016
Record last verified: 2015-11