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

Phase 4

Completed

• Conditions: Postoperative Sleep Quality
• Interventions: Drug: propofol; Drug: sevoflurane

• Registration Number: NCT02146976
• Lead Sponsor: China Medical University, China

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.

Study Timeline

• Study First Submitted: 2014-05-22
• Study First Submitted QC: 2014-05-23
• Study First Posted: 2014-05-26
• Study Start: 2014-10
• Primary Completion: 2015-09
• Study Completion: 2015-10
• Status Verified: 2015-11
• Last Update Submitted: 2016-01-28
• Last Update Posted: 2016-01-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 124

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Propofol	propofol	introvenious infusion of propofol
Inhaled anaesthetic (Sevoflurane)	sevoflurane	sevoflurane (1.0-1.3% Minimum Alveolar Concentration)

Primary Outcome Measures

Name	Time	Method
The Change of postoperative sleep quality	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.

Trial Locations

Locations (1)

the First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China