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
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
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.
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
NCT ID
NCT04103528
First Posted
September 20, 2019
Last Updated
September 24, 2019
Sponsor
General Hospital of Ningxia Medical University
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
Citations:
PubMed Identifier
26928796
Citation
Tan WF, Miao EY, Jin F, Ma H, Lu HW. Changes in First Postoperative Night Bispectral Index After Daytime Sedation Induced by Dexmedetomidine or Midazolam Under Regional Anesthesia: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 May-Jun;41(3):380-6. doi: 10.1097/AAP.0000000000000370.
Results Reference
background
PubMed Identifier
25294583
Citation
Brainard J, Gobel M, Bartels K, Scott B, Koeppen M, Eckle T. Circadian rhythms in anesthesia and critical care medicine: potential importance of circadian disruptions. Semin Cardiothorac Vasc Anesth. 2015 Mar;19(1):49-60. doi: 10.1177/1089253214553066. Epub 2014 Oct 7.
Results Reference
result
PubMed Identifier
8652329
Citation
Rosenberg-Adamsen S, Kehlet H, Dodds C, Rosenberg J. Postoperative sleep disturbances: mechanisms and clinical implications. Br J Anaesth. 1996 Apr;76(4):552-9. doi: 10.1093/bja/76.4.552. No abstract available.
Results Reference
result
PubMed Identifier
29103568
Citation
Hillman DR. Postoperative Sleep Disturbances: Understanding and Emerging Therapies. Adv Anesth. 2017;35(1):1-24. doi: 10.1016/j.aan.2017.07.001. Epub 2017 Sep 18. No abstract available.
Results Reference
result
PubMed Identifier
20601860
Citation
Royse CF, Newman S, Chung F, Stygall J, McKay RE, Boldt J, Servin FS, Hurtado I, Hannallah R, Yu B, Wilkinson DJ. Development and feasibility of a scale to assess postoperative recovery: the post-operative quality recovery scale. Anesthesiology. 2010 Oct;113(4):892-905. doi: 10.1097/ALN.0b013e3181d960a9.
Results Reference
result
PubMed Identifier
7733516
Citation
Beydon L, Rauss A, Lofaso F, Liu N, Cherqui D, Goldenberg F, Bonnet F. [Survey of the quality of sleep during the perioperative period. Study of factors predisposing to insomnia]. Ann Fr Anesth Reanim. 1994;13(5):669-74. doi: 10.1016/s0750-7658(05)80723-3. French.
Results Reference
result
PubMed Identifier
22893770
Citation
Kjolhede P, Langstrom P, Nilsson P, Wodlin NB, Nilsson L. The impact of quality of sleep on recovery from fast-track abdominal hysterectomy. J Clin Sleep Med. 2012 Aug 15;8(4):395-402. doi: 10.5664/jcsm.2032.
Results Reference
result
PubMed Identifier
29120927
Citation
Su X, Wang DX. Improve postoperative sleep: what can we do? Curr Opin Anaesthesiol. 2018 Feb;31(1):83-88. doi: 10.1097/ACO.0000000000000538.
Results Reference
result
PubMed Identifier
18037670
Citation
Gogenur I, Wildschiotz G, Rosenberg J. Circadian distribution of sleep phases after major abdominal surgery. Br J Anaesth. 2008 Jan;100(1):45-9. doi: 10.1093/bja/aem340. Epub 2007 Nov 23.
Results Reference
result
PubMed Identifier
22831887
Citation
Krenk L, Jennum P, Kehlet H. Sleep disturbances after fast-track hip and knee arthroplasty. Br J Anaesth. 2012 Nov;109(5):769-75. doi: 10.1093/bja/aes252. Epub 2012 Jul 24.
Results Reference
result
PubMed Identifier
18761566
Citation
Jan JE, Reiter RJ, Wasdell MB, Bax M. The role of the thalamus in sleep, pineal melatonin production, and circadian rhythm sleep disorders. J Pineal Res. 2009 Jan;46(1):1-7. doi: 10.1111/j.1600-079X.2008.00628.x. Epub 2008 Aug 28.
Results Reference
result
PubMed Identifier
11903069
Citation
Karkela J, Vakkuri O, Kaukinen S, Huang WQ, Pasanen M. The influence of anaesthesia and surgery on the circadian rhythm of melatonin. Acta Anaesthesiol Scand. 2002 Jan;46(1):30-6. doi: 10.1034/j.1399-6576.2002.460106.x.
Results Reference
result
PubMed Identifier
23689687
Citation
de Oliveira Tatsch-Dias M, Levandovski RM, Custodio de Souza IC, Gregianin Rocha M, Magno Fernandes PA, Torres IL, Hidalgo MP, Markus RP, Caumo W. The concept of the immune-pineal axis tested in patients undergoing an abdominal hysterectomy. Neuroimmunomodulation. 2013;20(4):205-12. doi: 10.1159/000347160. Epub 2013 May 8.
Results Reference
result
PubMed Identifier
29759277
Citation
Cao M, Javaheri S. Effects of Chronic Opioid Use on Sleep and Wake. Sleep Med Clin. 2018 Jun;13(2):271-281. doi: 10.1016/j.jsmc.2018.02.002. Epub 2018 Mar 12.
Results Reference
result
PubMed Identifier
17198534
Citation
Naguib M, Gottumukkala V, Goldstein PA. Melatonin and anesthesia: a clinical perspective. J Pineal Res. 2007 Jan;42(1):12-21. doi: 10.1111/j.1600-079X.2006.00384.x.
Results Reference
result
PubMed Identifier
22886841
Citation
Mihara T, Kikuchi T, Kamiya Y, Koga M, Uchimoto K, Kurahashi K, Goto T. Day or night administration of ketamine and pentobarbital differentially affect circadian rhythms of pineal melatonin secretion and locomotor activity in rats. Anesth Analg. 2012 Oct;115(4):805-13. doi: 10.1213/ANE.0b013e3182632bcb. Epub 2012 Aug 10.
Results Reference
result
PubMed Identifier
26887845
Citation
Li CX, An XX, Zhao B, Wu SJ, Xie GH, Fang XM. Impact of operation timing on post-operative infections following colorectal cancer surgery. ANZ J Surg. 2016 Apr;86(4):294-8. doi: 10.1111/ans.13471. Epub 2016 Feb 17.
Results Reference
result
PubMed Identifier
26578097
Citation
Gimenez S, Romero S, Alonso JF, Mananas MA, Pujol A, Baxarias P, Antonijoan RM. Monitoring sleep depth: analysis of bispectral index (BIS) based on polysomnographic recordings and sleep deprivation. J Clin Monit Comput. 2017 Feb;31(1):103-110. doi: 10.1007/s10877-015-9805-5. Epub 2015 Nov 14.
Results Reference
result
PubMed Identifier
26909151
Citation
Dolan R, Huh J, Tiwari N, Sproat T, Camilleri-Brennan J. A prospective analysis of sleep deprivation and disturbance in surgical patients. Ann Med Surg (Lond). 2016 Jan 6;6:1-5. doi: 10.1016/j.amsu.2015.12.046. eCollection 2016 Mar.
Results Reference
result
PubMed Identifier
11033374
Citation
Soldatos CR, Dikeos DG, Paparrigopoulos TJ. Athens Insomnia Scale: validation of an instrument based on ICD-10 criteria. J Psychosom Res. 2000 Jun;48(6):555-60. doi: 10.1016/s0022-3999(00)00095-7.
Results Reference
result
PubMed Identifier
36088298
Citation
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.
Results Reference
derived
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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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