Postoperative ComplicationsNCT04103528
Effects of Procedure Started in the Morning and Afternoon on Early Postoperative Sleep Function and Postoperative Recovery in Patients Under General Anesthesia
A study testing morning surgery and afternoon surgery in people with Postoperative Complications, run by General Hospital of Ningxia Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postoperative Complications
- What is being tested?
- morning surgery and afternoon surgery
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2018to 25 Jan 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- aged 18-60 years old.
- ASA status I or II.
- BMI 18.5-28 kg/m^2.
- performed with laparoscopic myomectomy.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
General hospital of Ningxia medical university
Yinchuan, Ningxia, 750004
About this study
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.
Read the 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.
- Conditions
- Postoperative Complications
- Being tested
- morning surgery, afternoon surgery
- Keywords
- Postoperative sleep disturbances, Postoperative recovery, General anesthesia, Early postoperative sleep, Procedure started in the morning and afternoon
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
morning surgeryOther
31 patients will be operated on between 8:00 and 12:00 in the morning.
afternoon surgeryOther
31 patients will be operated on between 14:00 and 18:00 in the afternoon.
| Study group | Role | What they receive |
|---|---|---|
| morning group(from 8:00 to 12:00) | Other | Not described Receives: Other: morning surgery |
| afternoon group(from 14:00 to 18:00) | Other | Not described Receives: Other: afternoon surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 day after the operation
Secondary outcomes (2)
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.
Measured: 1 day before surgery (T0), 30 minutes after end of anesthesia (T1), and 1 day after surgery (T2)
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.
Measured: 6am one day before and one day after the surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2019
- Study start9 Oct 2018
- Primary completion24 Jan 2019
- Study completion25 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Postoperative ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- General Hospital of Ningxia Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04103528
- Sponsor's protocol ID
- HHT
- Status last verified
- Sep 2019
- First submitted
- 20 Sep 2019
- Last updated
- 25 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 26928796Brainard 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.
PubMed 25294583Rosenberg-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.
PubMed 8652329Hillman 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.
PubMed 29103568Royse 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.
PubMed 20601860Beydon 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.
PubMed 7733516Kjolhede 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.
PubMed 22893770Su X, Wang DX. Improve postoperative sleep: what can we do? Curr Opin Anaesthesiol. 2018 Feb;31(1):83-88. doi: 10.1097/ACO.0000000000000538.
PubMed 29120927Gogenur 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.
PubMed 18037670Krenk 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.
PubMed 22831887Jan 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.
PubMed 18761566Karkela 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.
PubMed 11903069de 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.
PubMed 23689687Cao 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.
PubMed 29759277Naguib 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.
PubMed 17198534
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Procedure Started in the Morning and Afternoon on Early Postoperative Sleep Function and Postoperative Recovery in Patients Under General Anesthesia
- ClinicalTrials.gov ID
- NCT04103528
- Acronym / sponsor ID
- HHT
- Conditions
- Postoperative Complications
- Keywords
- Postoperative sleep disturbances, Postoperative recovery, General anesthesia, Early postoperative sleep, Procedure started in the morning and afternoon
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- General Hospital of Ningxia Medical UniversityUniversity, hospital or other
- Study start
- 9 Oct 2018 (actual)
- Primary completion
- 24 Jan 2019 (actual)
- Study completion
- 25 Jan 2019 (actual)
- First posted
- 25 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| morning group(from 8:00 to 12:00) | Other | Other: morning surgery |
| afternoon group(from 14:00 to 18:00) | Other | Other: afternoon surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- aged 18-60 years old.
- ASA status I or II.
- BMI 18.5-28 kg/m^2.
- performed with laparoscopic myomectomy.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| morning surgery31 patients will be operated on between 8:00 and 12:00 in the morning. | Other | morning group(from 8:00 to 12:00) |
| afternoon surgery31 patients will be operated on between 14:00 and 18:00 in the afternoon. | Other | afternoon group(from 14:00 to 18:00) |
Primary outcome
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
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.
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.
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.
2 secondary outcomes
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)
The biochemical indicators
Time frame: 6am one day before and one day after the surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2019.
- Background: PubMed 26928796Tan 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 publication: PubMed 25294583Brainard 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 publication: PubMed 8652329Rosenberg-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 publication: PubMed 29103568Hillman 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 publication: PubMed 20601860Royse 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 publication: PubMed 7733516Beydon 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 publication: PubMed 22893770Kjolhede 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 publication: PubMed 29120927Su 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 publication: PubMed 18037670Gogenur 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 publication: PubMed 22831887Krenk 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 publication: PubMed 18761566Jan 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 publication: PubMed 11903069Karkela 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing morning surgery and afternoon surgery in people with Postoperative Complications, run by General Hospital of Ningxia Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of postoperative sleep disturbances by Athens Insomnia Scale (time frame: 1 day after the operation). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04103528, which also lists 21 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2019.