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

NCT04103528 | Completed DMC

• 1 other identifier: HHT
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Complications

Keywords

Postoperative sleep disturbances; Postoperative recovery; General anesthesia; Early postoperative sleep; Procedure started in the morning and afternoon

Outcome Measures

Primary Outcomes (4)

• The incidence of postoperative sleep disturbances by Athens Insomnia Scale

  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

  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

  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

  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 Outcomes (2)

• Postoperative recovery Post-operative Quality Recovery Scale(PQRS)

  1 day before surgery (T0), 30 minutes after end of anesthesia (T1), and 1 day after surgery (T2)

• The biochemical indicators

  6am one day before and one day after the surgery

Study Arms (2)

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

OTHER

Other: morning surgery

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

OTHER

Other: afternoon surgery

Interventions

morning surgery OTHER

31 patients will be operated on between 8:00 and 12:00 in the morning.

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

afternoon surgery OTHER

31 patients will be operated on between 14:00 and 18:00 in the afternoon.

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

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• General Hospital of Ningxia Medical University: lead

Study Sites (1)

General hospital of Ningxia medical university

Yinchuan, Ningxia, 750004, China

Location

Related Publications (21)

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• Hou H, Wu S, Qiu Y, Song F, Deng L. The effects of morning/afternoon surgeries on the early postoperative sleep quality of patients undergoing general anesthesia. BMC Anesthesiol. 2022 Sep 10;22(1):286. doi: 10.1186/s12871-022-01828-w.

  PMID: 36088298 DERIVED

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2019
• First Posted: September 25, 2019
• Study Start: October 9, 2018
• Primary Completion: January 24, 2019
• Study Completion: January 25, 2019
• Last Updated: September 25, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)