Clinical trial NCT04103528: 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
Overall status: COMPLETED
Phase: NA
Conditions: Postoperative Complications
Keywords: Postoperative sleep disturbances
Postoperative recovery
General anesthesia
Early postoperative sleep
Procedure started in the morning and afternoon
Lead sponsor: General Hospital of Ningxia Medical University
Sponsor class: OTHER
First posted: 2019-09-25
Enrollment: 62
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The incidence of postoperative sleep disturbances by Athens Insomnia Scale
timeFrame: 1 day after the operation
measure: The sleep time by bispectral index(BIS) monitor from 21:00 to 06:00 on the first night after surgery
timeFrame: 1 day after the operation
measure: The sleep efficiency by bispectral index(BIS) monitor from 21:00 to 06:00 on the first night after surgery
timeFrame: 1 day after the operation
measure: The sleep quality by bispectral index(BIS) monitor from 21:00 to 06:00 on the first night after surgery
timeFrame: 1 day after the operation
Secondary outcomes:
measure: Postoperative recovery Post-operative Quality Recovery Scale(PQRS)
timeFrame: 1 day before surgery (T0), 30 minutes after end of anesthesia (T1), and 1 day after surgery (T2)
measure: The biochemical indicators
timeFrame: 6am one day before and one day after the surgery
Other outcomes:
Locations:
city: Yinchuan
country: China
facility: General hospital of Ningxia medical university
state: Ningxia
Study officials:
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