Postoperative Sleep QualityNCT04123249
The Effects of Intravenous Anesthetics and Inhaled Anesthetics on Patients' Postoperative Sleep
A study testing Propofol and Sevoflurane in people with Postoperative Sleep Quality and General Anesthesia, run by Yanchao Yang at 1 site in China.
Trial summary
Adequate sleep is necessary for physical and mental health of human being. Although surgery and anesthesia techniques have improved in resent years, postoperative sleep disturbance remains a challenging problem in surgical procedures1. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Sleep Quality, General Anesthesia, Propofol
- What is being tested?
- Propofol and Sevoflurane
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2020to 30 Nov 2020
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA : GradeⅠtoⅡ Laparoscopic surgery
Who cannot join
- history of sleep apnea; severe neuropsychiatric disorders; long-term use of sedatives or sleeping pills; can not implement multi-lead sleep monitoring and other sleep disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Intravenous Anesthetics vs Inhaled Anesthetics on Early Postoperative Sleep Quality and Complications of Patients After Laparoscopic Surgery Under General Anesthesia
Adequate sleep is necessary for physical and mental health of human being. Although surgery and anesthesia techniques have improved in resent years, postoperative sleep disturbance remains a challenging problem in surgical procedures1. Postoperative sleep fragmentation and poor sleep quality can not only result in hyperalgesia and a delay in postoperative recovery2, lack of sleep after surgery can also bring many potential adverse effects such as cognitive disorders (such as delusions, delirium), chronic pain, mood disorders, metabolic disorders, and pro-inflammatory changes3-5. Previous studies have reported that age, preoperative comorbidity and severity of surgical trauma were independent factors that associated with postoperative sleep disturbance6,7. Our prior studies have also found that patients are more likely to experience decreased sleep quality after receiving general anesthesia, which was characterized by a decrease in each sleep stage8. Propofol and sevoflurane are commonly used general anesthetics in clinical practice. The choice of anesthetic may also affect the cognitive outcome after surgery, but the results of clinical studies have always been contradictory. Some studies report that the cognitive results after inhalation are worse than those after intravenous anesthesia. And the incidence of dreaming was significantly higher in the sevoflurane anesthesia group compared to the propofol group9-11. Another study conduct among infants proved that compared with propofol-remifentanil, sevoflurane appears to be associated with less sleep disturbances in the first weeks after surgery12. Based on these conflicts, the aim of the current study was to compare the effect of propofol vs sevoflurane on early postoperative sleep quality and complications of patients receiving laparoscopic surgery after general anesthesia.
- Conditions
- Postoperative Sleep Quality, General Anesthesia, Propofol, Sevoflurane, Dreaming
- Being tested
- Propofol, Sevoflurane
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PropofolDrug
Also called Intravenous Anesthetics
Group Propofol was given propofol 4mg/kg/h intravenous pumping to assist sedation
SevofluraneDrug
Also called Inhaled Anesthetics
Group Sevoflurane was given sevoflurane inhalation maintenance (concentration of 2% to 3% and mixed with 50% oxygen and air) to assist sedation；
| Study group | Role | What they receive |
|---|---|---|
| Group Propofol | Experimental | In the Group P, propofol 4-6 mg/kg/h and remifentanil 0.2μg/kg/min were infused by intravenous pump separately for assisted sedation and assisted analgesia. Receives: Drug: Propofol |
| Group Sevoflurane | Experimental | sevoflurane (concentration: 2%-3%, mixed with 50% air and 50% oxygen to keep the minimum alveolar concentration (MAC) at 1.0-1.1) was inhaled to maintain assisted sedation, and remifentanil 0.2 μg/kg/min was infused by intravenous pump for assisted analgesia. Receives: Drug: Sevoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative sleep quality of one night before surgery
Use sleep monitor to test the sleep quality one night before surgery
Measured: one night after the surgery
postoperative sleep quality of the first night after surgery
Use sleep monitor to test the sleep quality the first night after surgery
Measured: the first night after surgery
postoperative sleep quality of the third night after surgery
Use sleep monitor to test the sleep quality the third night after surgery
Measured: the third night after surgery
Secondary outcomes (2)
Postoperative pain score
Use visual analog scale (VAS) score, where 0 means no pain and 10 means severe pain,to evaluate pain scores after surgery
Measured: 24h after surgery
postoperative adverse effect
record the adverse reactions such as respiratory depression, bradycardia, nausea, vomiting and dizziness within 24 hours after surgery
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start20 May 2020
- Primary completion1 Nov 2020
- Study completion30 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Sleep QualityStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yanchao Yang
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanchao Yang, Shengjing Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04123249
- Sponsor's protocol ID
- general anesthetics and sleep
- Status last verified
- Jan 2021
- First submitted
- 9 Oct 2019
- Last updated
- 5 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intravenous Anesthetics vs Inhaled Anesthetics on Early Postoperative Sleep Quality and Complications of Patients After Laparoscopic Surgery Under General Anesthesia
- ClinicalTrials.gov ID
- NCT04123249
- Acronym / sponsor ID
- general anesthetics and sleep
- Conditions
- Postoperative Sleep Quality, General Anesthesia, Propofol, Sevoflurane, Dreaming
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Yanchao YangUniversity, hospital or other
- Study start
- 20 May 2020 (actual)
- Primary completion
- 1 Nov 2020 (actual)
- Study completion
- 30 Nov 2020 (actual)
- First posted
- 10 Oct 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.
Adequate sleep is necessary for physical and mental health of human being. Although surgery and anesthesia techniques have improved in resent years, postoperative sleep disturbance remains a challenging problem in surgical procedures1. Postoperative sleep fragmentation and poor sleep quality can not only result in hyperalgesia and a delay in postoperative recovery2, lack of sleep after surgery can also bring many potential adverse effects such as cognitive disorders (such as delusions, delirium), chronic pain, mood disorders, metabolic disorders, and pro-inflammatory changes3-5. Previous studies have reported that age, preoperative comorbidity and severity of surgical trauma were independent factors that associated with postoperative sleep disturbance6,7. Our prior studies have also found that patients are more likely to experience decreased sleep quality after receiving general anesthesia, which was characterized by a decrease in each sleep stage8. Propofol and sevoflurane are commonly used general anesthetics in clinical practice. The choice of anesthetic may also affect the cognitive outcome after surgery, but the results of clinical studies have always been contradictory. Some studies report that the cognitive results after inhalation are worse than those after intravenous anesthesia. And the incidence of dreaming was significantly higher in the sevoflurane anesthesia group compared to the propofol group9-11. Another study conduct among infants proved that compared with propofol-remifentanil, sevoflurane appears to be associated with less sleep disturbances in the first weeks after surgery12. Based on these conflicts, the aim of the current study was to compare the effect of propofol vs sevoflurane on early postoperative sleep quality and complications of patients receiving laparoscopic surgery after general anesthesia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group Propofol | Experimental | Drug: PropofolIn the Group P, propofol 4-6 mg/kg/h and remifentanil 0.2μg/kg/min were infused by intravenous pump separately for assisted sedation and assisted analgesia. |
| Group Sevoflurane | Experimental | Drug: Sevofluranesevoflurane (concentration: 2%-3%, mixed with 50% air and 50% oxygen to keep the minimum alveolar concentration (MAC) at 1.0-1.1) was inhaled to maintain assisted sedation, and remifentanil 0.2 μg/kg/min was infused by intravenous pump for assisted analgesia. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- ASA : GradeⅠtoⅡ Laparoscopic surgery
Key exclusion criteria (1 listed)
- history of sleep apnea; severe neuropsychiatric disorders; long-term use of sedatives or sleeping pills; can not implement multi-lead sleep monitoring and other sleep disorders
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 |
|---|---|---|
| PropofolAlso: Intravenous AnestheticsGroup Propofol was given propofol 4mg/kg/h intravenous pumping to assist sedation | Drug | Group Propofol |
| SevofluraneAlso: Inhaled AnestheticsGroup Sevoflurane was given sevoflurane inhalation maintenance (concentration of 2% to 3% and mixed with 50% oxygen and air) to assist sedation； | Drug | Group Sevoflurane |
Primary outcome
postoperative sleep quality of one night before surgery
Time frame: one night after the surgery
Use sleep monitor to test the sleep quality one night before surgery
postoperative sleep quality of the first night after surgery
Time frame: the first night after surgery
Use sleep monitor to test the sleep quality the first night after surgery
postoperative sleep quality of the third night after surgery
Time frame: the third night after surgery
Use sleep monitor to test the sleep quality the third night after surgery
2 secondary outcomes
Postoperative pain score
Time frame: 24h after surgery
postoperative adverse effect
Time frame: 24 hours after 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 5 Jan 2021.
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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 Propofol and Sevoflurane in people with Postoperative Sleep Quality and General Anesthesia, run by Yanchao Yang 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 1 inclusion and 1 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 5 Jan 2021. 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?
postoperative sleep quality of one night before surgery (time frame: one night after the surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Jan 2021.