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

Sponsor

China Medical University, China (Other)

Overall Status

Completed

CT.gov ID

NCT02146976

Collaborator

(none)

124

Enrollment

Location

Arms

Duration (Months)

10.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Postoperative Sleep Quality	Drug: propofol Drug: sevoflurane	Phase 4

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 Design

Study Type:

Interventional

Actual Enrollment :

124 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Oct 1, 2014

Actual Primary Completion Date :

Sep 1, 2015

Actual Study Completion Date :

Oct 1, 2015

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.