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Clinical Trials/NCT02146976
NCT02146976
Completed
Phase 4

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

China Medical University, China1 site in 1 country124 target enrollmentOctober 2014

Overview

Phase
Phase 4
Intervention
propofol
Conditions
Postoperative Sleep Quality
Sponsor
China Medical University, China
Enrollment
124
Locations
1
Primary Endpoint
The Change of postoperative sleep quality
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
October 2014
End Date
October 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Wen-fei Tan

Associate Professor

China Medical University, China

Eligibility Criteria

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.

Arms & Interventions

Propofol

introvenious infusion of propofol

Intervention: propofol

Inhaled anaesthetic (Sevoflurane)

sevoflurane (1.0-1.3% Minimum Alveolar Concentration)

Intervention: sevoflurane

Outcomes

Primary Outcomes

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.

Study Sites (1)

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