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出境医 / 临床实验 / The Effect of Intraoperative Use of Dexmedetomidine During the Daytime Operation vs the Nighttime Operation on Postoperative Sleep Quality and Pain Under General Anesthesia
The Effect of Intraoperative Use of Dexmedetomidine During the Daytime Operation vs the Nighttime Operation on Postoperative Sleep Quality and Pain Under General Anesthesia
Study Description
Brief Summary:
General anesthesia is a medically induced state of low reactivity consciousness which is similar to natural sleep. Some studies found that general anesthesia as an independent risk factor could result in a desynchronization of the circadian time structure and cause postoperative sleep disorders characterized by reduced rapid eye movement (REM) and slow wave sleep (SWS), which have significant deleterious impacts on postoperative outcomes, such as postoperative fatigue, severe anxiety and depression, emotional detachment and delirium, and even pain sensitivity or postoperative pain of patients.Clinical trials have already proved that intraoperative use of dexmedetomidine (DEX) for general anesthesia, a highly selective alpha-2 adrenergic agonist, was able to improve sedative and analgesia effects and promote sleep quality (by decreasing stage N1 sleep, increasing stage N2 sleep and sleep efficiency). However, Wenfei Tan et al reported that with the deeper sedative state provided by DEX in the daytime, the elderly male patients undergoing TURP under spinal anesthesia suffered worse sleep on the night of surgery. Thus, what the effect of intraoperative using DEX at different time periods under general anesthesia on postoperative sleep quality and pain will be needs further study.
| Condition or disease | Intervention/treatment |
|---|---|
| Postoperative Pain Postoperative Sleep Quality Intraoperative Dexmedetomidine General Anesthesia | Other: time of receiving operation |
Detailed Description:
patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were enrolled. Patients were randomized to receive operation in the D group (8:00-12:00) and the N group (18:00-22:00). The Portable Sleep Monitor (PSM) was performed on the following 3 nights: the night before surgery (Sleep1), the first night after surgery (Sleep 2), and the third night after surgery (Sleep 3). Postoperative pain scores using visual analogue scoring scale, subjective sleep quality using the Athens Insomnia Scale, total dose of general anesthetics and PCA pump press numbers were also recorded.
Study Design
| Study Type : | Observational |
| Estimated Enrollment : | 75 participants |
| Observational Model: | Other |
| Time Perspective: | Prospective |
| Official Title: | The Effect of Intraoperative Use of Dexmedetomidine During the Daytime Operation vs the Nighttime Operation on Postoperative Sleep Quality and Pain Under General Anesthesia |
| Actual Study Start Date : | June 15, 2019 |
| Estimated Primary Completion Date : | November 30, 2019 |
| Estimated Study Completion Date : | December 31, 2019 |
Arms and Interventions
| Group/Cohort | Intervention/treatment |
|---|---|
|
Day group
patients in Day group accept operation from 8：00～12：00
|
Other: time of receiving operation
patients were randomly divided into Day group (D group) (8：00～12：00) and Night group (N group) (18：00～22：00), Patients received propofol, remifentanil, and DEX for general anesthesia maintenance
|
|
Night group
patients in Night group accept operation from 18：00～22：00
|
Other: time of receiving operation
patients were randomly divided into Day group (D group) (8：00～12：00) and Night group (N group) (18：00～22：00), Patients received propofol, remifentanil, and DEX for general anesthesia maintenance
|
Outcome Measures
Primary Outcome Measures :
- Sleep quality of one night before the surgery [ Time Frame: one night before the surgery ]Use sleep monitor to test the sleep quality on one night before the surgery
- Sleep quality of first night after the surgery [ Time Frame: the first night after the surgery ]Use sleep monitor to test the sleep quality on the first night after the surgery
- Sleep quality of third night after the surgery [ Time Frame: the third night after the surgery ]Use sleep monitor to test the sleep quality on the third night after the surgery
Secondary Outcome Measures :
- Visual analog scale (VAS) [ Time Frame: 1,6,24,48 hours after the surgery ]Evaluate the VAS score at 1,6,24,48 hours after the surgery.Visual analog scale (VAS) score of 0 was considered painless, and a score of 10 was considered as intense pain. Scores of 4 and below were considered mild pain (pain does not affect sleep), and scores of 5 to 6 were considered moderate pain (pain influences sleep, but the patients can still fall asleep). Scores of 7 and above were considered severe pain (Due to the pain the patient is unable to sleep or wakes up)
- PCA pump press number [ Time Frame: 48 hours after the surgery ]Evaluate the Pump press number 48 hours after the surgery
Eligibility Criteria
| Ages Eligible for Study: | 30 Years to 55 Years (Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Patients who underwent elective laparoscopic abdominal surgeries under general anesthesia at Shengjing Hospital of China Medical University were enrolled in this study
Criteria
Inclusion Criteria:
age between 30 and 55 years American Society of Anaesthesiologists physical status I or II.
Exclusion Criteria:
cardiovascular disease long term use of analgesia preoperative heart rate (HR) less than 50 beats/min second- or third-degree atrioventricular block sleep disorder sleep apnea syndrome history of abnormal operation or anesthesia recovery psychosis or a patient with a language communication disorder not willing to cooperate with the experimenter.
Contacts and Locations
Contacts
| Contact: bijia Song | 18309845273 ext 18309845273 | 630992254@qq.com | |
| Contact: Junchao Zhu | 18940257257 ext 18940257257 | zhujunchao1@hotmail.com |
Locations
| China, Liao Ning | |
| shengjing hospital of China medical university | Recruiting |
| Shenyang, Liao Ning, China, 110004 | |
| Contact: Zhu junchao, doctor 18940257257 zhujunchao1@hotmail.com | |
| Contact: Song bijia, master 18309845273 630992254@qq.com | |
Sponsors and Collaborators
Shengjing Hospital
Investigators
| Study Director: | Junchao Zhu | Shengjing Hospital |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 11, 2019 | ||||||||
| First Posted Date | June 19, 2019 | ||||||||
| Last Update Posted Date | September 19, 2019 | ||||||||
| Actual Study Start Date | June 15, 2019 | ||||||||
| Estimated Primary Completion Date | November 30, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
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| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
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| Original Secondary Outcome Measures |
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| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | The Effect of Intraoperative Use of Dexmedetomidine During the Daytime Operation vs the Nighttime Operation on Postoperative Sleep Quality and Pain Under General Anesthesia | ||||||||
| Official Title | The Effect of Intraoperative Use of Dexmedetomidine During the Daytime Operation vs the Nighttime Operation on Postoperative Sleep Quality and Pain Under General Anesthesia | ||||||||
| Brief Summary | General anesthesia is a medically induced state of low reactivity consciousness which is similar to natural sleep. Some studies found that general anesthesia as an independent risk factor could result in a desynchronization of the circadian time structure and cause postoperative sleep disorders characterized by reduced rapid eye movement (REM) and slow wave sleep (SWS), which have significant deleterious impacts on postoperative outcomes, such as postoperative fatigue, severe anxiety and depression, emotional detachment and delirium, and even pain sensitivity or postoperative pain of patients.Clinical trials have already proved that intraoperative use of dexmedetomidine (DEX) for general anesthesia, a highly selective alpha-2 adrenergic agonist, was able to improve sedative and analgesia effects and promote sleep quality (by decreasing stage N1 sleep, increasing stage N2 sleep and sleep efficiency). However, Wenfei Tan et al reported that with the deeper sedative state provided by DEX in the daytime, the elderly male patients undergoing TURP under spinal anesthesia suffered worse sleep on the night of surgery. Thus, what the effect of intraoperative using DEX at different time periods under general anesthesia on postoperative sleep quality and pain will be needs further study. | ||||||||
| Detailed Description | patients scheduled for elective laparoscopic abdominal surgeries under general anesthesia were enrolled. Patients were randomized to receive operation in the D group (8:00-12:00) and the N group (18:00-22:00). The Portable Sleep Monitor (PSM) was performed on the following 3 nights: the night before surgery (Sleep1), the first night after surgery (Sleep 2), and the third night after surgery (Sleep 3). Postoperative pain scores using visual analogue scoring scale, subjective sleep quality using the Athens Insomnia Scale, total dose of general anesthetics and PCA pump press numbers were also recorded. | ||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Other Time Perspective: Prospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | Patients who underwent elective laparoscopic abdominal surgeries under general anesthesia at Shengjing Hospital of China Medical University were enrolled in this study | ||||||||
| Condition |
|
||||||||
| Intervention | Other: time of receiving operation
patients were randomly divided into Day group (D group) (8：00～12：00) and Night group (N group) (18：00～22：00), Patients received propofol, remifentanil, and DEX for general anesthesia maintenance
|
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| Study Groups/Cohorts |
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| Publications * | Not Provided | ||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
75 | ||||||||
| Original Estimated Enrollment |
80 | ||||||||
| Estimated Study Completion Date | December 31, 2019 | ||||||||
| Estimated Primary Completion Date | November 30, 2019 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria: age between 30 and 55 years American Society of Anaesthesiologists physical status I or II. Exclusion Criteria: cardiovascular disease long term use of analgesia preoperative heart rate (HR) less than 50 beats/min second- or third-degree atrioventricular block sleep disorder sleep apnea syndrome history of abnormal operation or anesthesia recovery psychosis or a patient with a language communication disorder not willing to cooperate with the experimenter. |
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| Sex/Gender |
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| Ages | 30 Years to 55 Years (Adult) | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts |
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| Listed Location Countries | China | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03990987 | ||||||||
| Other Study ID Numbers | Dexmedetomidine and sleep | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement | Not Provided | ||||||||
| Responsible Party | Yanchao Yang, Shengjing Hospital | ||||||||
| Study Sponsor | Shengjing Hospital | ||||||||
| Collaborators | Not Provided | ||||||||
| Investigators |
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| PRS Account | Shengjing Hospital | ||||||||
| Verification Date | July 2019 | ||||||||
