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Effects of Procedure Started in the Morning and Afternoon on Early Postoperative Sleep Function and Postoperative Recovery in Patients Under General Anesthesia

Primary Purpose

Postoperative Complications

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
morning surgery
afternoon surgery
Sponsored by
General Hospital of Ningxia Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Postoperative Complications focused on measuring Postoperative sleep disturbances, Postoperative recovery, General anesthesia, Early postoperative sleep, Procedure started in the morning and afternoon

Eligibility Criteria

18 Years - 60 Years (Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. aged 18-60 years old.
  2. ASA status I or II.
  3. BMI 18.5-28 kg/m^2.
  4. performed with laparoscopic myomectomy.

Exclusion Criteria:

  1. combining with ovarian disease or ovarian surgery.
  2. preoperative Athens Insomnia Scale (AIS) score ≥ 4 points
  3. chronic use of sedative, hypnotic, psychotropic drugs.
  4. recent night shift, cross-time zone, irregular life routine.
  5. suffering from mental illness or hearing, visual impairment, and existing sleep apnea syndrome.
  6. patients withdraw, or were unable to complete the trial after surgery.
  7. lossed bleeding volume more than 500 ml during surgery.
  8. performed procedure time exceeded 2 h.

Sites / Locations

  • General hospital of Ningxia medical university

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

morning group(from 8:00 to 12:00)

afternoon group(from 14:00 to 18:00)

Arm Description

Outcomes

Primary Outcome Measures

The incidence of postoperative sleep disturbances by Athens Insomnia Scale
Postoperative sleep disturbances were defined as the total score of Athens Insomnia Scale more than 6. The incidence of postoperative sleep disturbances was defined as the percentage of the population with a score greater than 6
The sleep time by bispectral index(BIS) monitor from 21:00 to 06:00 on the first night after surgery
The sleep time: was defined as the total time of BIS values less than 80 during monitoring.
The sleep efficiency by bispectral index(BIS) monitor from 21:00 to 06:00 on the first night after surgery
The sleep efficiency: was defined as the ratio of a sleeping time over monitoring time.
The sleep quality by bispectral index(BIS) monitor from 21:00 to 06:00 on the first night after surgery
The sleep quality: was assessed by the area under curve of BIS (BIS-AUC). The BIS-AUC was calculate using the trapezoidal rule, which used trapezium to approximate the region under a curve and calculate its area (GraphPad Prism Version 5.01; San Diego, California). The smaller BIS-AUC was the better sleep quality.

Secondary Outcome Measures

Postoperative recovery Post-operative Quality Recovery Scale(PQRS)
Postoperative Quality Recovery Scale includes five parts: physiological functions (blood pressure, heart rate, temperature, ventilation rate, maintenance of oxygen saturation, airway maintenance, agitation, consciousness, response), Nociceptive (pain, nausea), emotional (depression, anxious), activities of daily living (ability to stand, walk, eat, dress), cognitive function (orientation, digits forward, digits backward, word list, word generation). According to the recovery situation: the physiological function is divided into three levels (3 points: acceptable, 2: abnormality, 1: extreme abnormality), nociceptive, emotional change according to the degree of Likert 5 scored (5: very satisfactory, 4: satisfactory, 3: general, 2: not satisfied, 1: very dissatisfied), and the activities of daily living are equally divided into three levels (3: easy, 2: difficulty, 1: it can't be done completely), when cognitive function score reaches the preoperative baseline level,it means recovery.
The biochemical indicators
The levels of melatonin (MT), cortisol, and glulcose in the blood were measured separately by ELISA at 6:00am 1 day before and 1 day after surgery.

Full Information

First Posted
September 20, 2019
Last Updated
September 24, 2019
Sponsor
General Hospital of Ningxia Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04103528
Brief Title
Effects of Procedure Started in the Morning and Afternoon on Early Postoperative Sleep Function and Postoperative Recovery in Patients Under General Anesthesia
Official Title
Effects of Procedure Started in the Morning and Afternoon on Early Postoperative Sleep Function and Postoperative Recovery in Patients Under General Anesthesia
Study Type
Interventional

2. Study Status

Record Verification Date
September 2019
Overall Recruitment Status
Completed
Study Start Date
October 9, 2018 (Actual)
Primary Completion Date
January 24, 2019 (Actual)
Study Completion Date
January 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
General Hospital of Ningxia Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The present study was conducted in laparoscopic hysteromyoma patients, aiming to compare the effects of morning surgery with afternoon surgery on early postoperative sleep function and postoperative recovery under general anesthesia.
Detailed Description
The circadian rhythm is an intrinsic timing mechanism generated by endogenous systems to adapt to the external environment, which is closely related to the human sleep-wake cycle. Patients after major surgery are prone to changes in sleep structure and sleep quality, called postoperative sleep disturbances (POSD), which are characterized by the total sleep time reduced, rapid eye movement sleep absent, slow wave sleep shortened, and shallow sleep phase increased, times of wakefulness increased, and highly fragmented sleep. Some studies have shown that POSD can aggravate postoperative pain and fatigue, increase postoperative delirium, cardiovascular adverse events, and even cause accidental death of patients. The investigators don't know whether the early postoperative sleep function and postoperative recovery quality of patients undergoing general anesthesia are affected by surgery in the morning or in the afternoon. The present study was conducted in laparoscopic hysteromyoma patients, aiming to compare the effects of morning surgery with afternoon surgery on early postoperative sleep function and postoperative recovery under general anesthesia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Complications
Keywords
Postoperative sleep disturbances, Postoperative recovery, General anesthesia, Early postoperative sleep, Procedure started in the morning and afternoon

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
morning group(from 8:00 to 12:00)
Arm Type
Other
Arm Title
afternoon group(from 14:00 to 18:00)
Arm Type
Other
Intervention Type
Other
Intervention Name(s)
morning surgery
Intervention Description
31 patients will be operated on between 8:00 and 12:00 in the morning.
Intervention Type
Other
Intervention Name(s)
afternoon surgery
Intervention Description
31 patients will be operated on between 14:00 and 18:00 in the afternoon.
Primary Outcome Measure Information:
Title
The incidence of postoperative sleep disturbances by Athens Insomnia Scale
Description
Postoperative sleep disturbances were defined as the total score of Athens Insomnia Scale more than 6. The incidence of postoperative sleep disturbances was defined as the percentage of the population with a score greater than 6
Time Frame
1 day after the operation
Title
The sleep time by bispectral index(BIS) monitor from 21:00 to 06:00 on the first night after surgery
Description
The sleep time: was defined as the total time of BIS values less than 80 during monitoring.
Time Frame
1 day after the operation
Title
The sleep efficiency by bispectral index(BIS) monitor from 21:00 to 06:00 on the first night after surgery
Description
The sleep efficiency: was defined as the ratio of a sleeping time over monitoring time.
Time Frame
1 day after the operation
Title
The sleep quality by bispectral index(BIS) monitor from 21:00 to 06:00 on the first night after surgery
Description
The sleep quality: was assessed by the area under curve of BIS (BIS-AUC). The BIS-AUC was calculate using the trapezoidal rule, which used trapezium to approximate the region under a curve and calculate its area (GraphPad Prism Version 5.01; San Diego, California). The smaller BIS-AUC was the better sleep quality.
Time Frame
1 day after the operation
Secondary Outcome Measure Information:
Title
Postoperative recovery Post-operative Quality Recovery Scale(PQRS)
Description
Postoperative Quality Recovery Scale includes five parts: physiological functions (blood pressure, heart rate, temperature, ventilation rate, maintenance of oxygen saturation, airway maintenance, agitation, consciousness, response), Nociceptive (pain, nausea), emotional (depression, anxious), activities of daily living (ability to stand, walk, eat, dress), cognitive function (orientation, digits forward, digits backward, word list, word generation). According to the recovery situation: the physiological function is divided into three levels (3 points: acceptable, 2: abnormality, 1: extreme abnormality), nociceptive, emotional change according to the degree of Likert 5 scored (5: very satisfactory, 4: satisfactory, 3: general, 2: not satisfied, 1: very dissatisfied), and the activities of daily living are equally divided into three levels (3: easy, 2: difficulty, 1: it can't be done completely), when cognitive function score reaches the preoperative baseline level,it means recovery.
Time Frame
1 day before surgery (T0), 30 minutes after end of anesthesia (T1), and 1 day after surgery (T2)
Title
The biochemical indicators
Description
The levels of melatonin (MT), cortisol, and glulcose in the blood were measured separately by ELISA at 6:00am 1 day before and 1 day after surgery.
Time Frame
6am one day before and one day after the surgery

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: aged 18-60 years old. ASA status I or II. BMI 18.5-28 kg/m^2. performed with laparoscopic myomectomy. Exclusion Criteria: combining with ovarian disease or ovarian surgery. preoperative Athens Insomnia Scale (AIS) score ≥ 4 points chronic use of sedative, hypnotic, psychotropic drugs. recent night shift, cross-time zone, irregular life routine. suffering from mental illness or hearing, visual impairment, and existing sleep apnea syndrome. patients withdraw, or were unable to complete the trial after surgery. lossed bleeding volume more than 500 ml during surgery. performed procedure time exceeded 2 h.
Facility Information:
Facility Name
General hospital of Ningxia medical university
City
Yinchuan
State/Province
Ningxia
ZIP/Postal Code
750004
Country
China

12. IPD Sharing Statement

Plan to Share IPD
No
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Effects of Procedure Started in the Morning and Afternoon on Early Postoperative Sleep Function and Postoperative Recovery in Patients Under General Anesthesia

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