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

September 24, 2019 updated by: General Hospital of Ningxia Medical University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • General Hospital of Ningxia Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
OTHER: morning group(from 8:00 to 12:00)
Other: morning surgery
31 patients will be operated on between 8:00 and 12:00 in the morning.
OTHER: afternoon group(from 14:00 to 18:00)
Other: afternoon surgery
31 patients will be operated on between 14:00 and 18:00 in the afternoon.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The incidence of postoperative sleep disturbances by Athens Insomnia Scale
Time Frame: 1 day after the operation
  1. Postoperative sleep disturbances were defined as the total score of Athens Insomnia Scale more than 6.
  2. The incidence of postoperative sleep disturbances was defined as the percentage of the population with a score greater than 6
1 day after the operation
The sleep time by bispectral index(BIS) monitor from 21:00 to 06:00 on the first night after surgery
Time Frame: 1 day after the operation
The sleep time: was defined as the total time of BIS values less than 80 during monitoring.
1 day after the operation
The sleep efficiency by bispectral index(BIS) monitor from 21:00 to 06:00 on the first night after surgery
Time Frame: 1 day after the operation
The sleep efficiency: was defined as the ratio of a sleeping time over monitoring time.
1 day after the operation
The sleep quality by bispectral index(BIS) monitor from 21:00 to 06:00 on the first night after surgery
Time Frame: 1 day after the operation
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.
1 day after the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative recovery Post-operative Quality Recovery Scale(PQRS)
Time Frame: 1 day before surgery (T0), 30 minutes after end of anesthesia (T1), and 1 day after surgery (T2)
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.
1 day before surgery (T0), 30 minutes after end of anesthesia (T1), and 1 day after surgery (T2)
The biochemical indicators
Time Frame: 6am one day before and one day after the surgery
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.
6am one day before and one day after the surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

General Hospital of Ningxia Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 9, 2018

Primary Completion (ACTUAL)

January 24, 2019

Study Completion (ACTUAL)

January 25, 2019

Study Registration Dates

First Submitted

September 20, 2019

First Submitted That Met QC Criteria

September 24, 2019

First Posted (ACTUAL)

September 25, 2019

Study Record Updates

Last Update Posted (ACTUAL)

September 25, 2019

Last Update Submitted That Met QC Criteria

September 24, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HHT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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