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

Postoperative Sleep Quality Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02146976
• Other study ID #: 20140522
• Status: Completed
• Phase: Phase 4
• First received: May 22, 2014
• Last updated: January 28, 2016
• Start date: October 2014
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: China Medical University, China
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 124
• Est. completion date: October 2015
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative Sleep Quality

Intervention

Drug:
• propofol
introvenious infusion of propofol
• sevoflurane
sevoflurane (1.0-1.3 Minimum Alveolar Concentration)

Locations

Country	Name	City	State
China	the First Hospital of China Medical University	Shenyang	Liaoning

Sponsors (1)

Lead Sponsor	Collaborator
China Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes