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Opioid-Free AnesthesiaNCT06493396

Effect of Opioid-free Anesthesia on Sleep Quality, Cognitive Function and Recovery Quality After General Anesthesia in Elderly Patients

A study testing Opioid-free Analgesics and Opioid group in people with Opioid-Free Anesthesia and POCD, run by Beijing Friendship Hospital.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record
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Trial summary

Postoperative cognitive dysfunction (POCD)is a common well disorder of the central nervous system after surgery, mainly manifested by impaired memory, spirit, language ability or other aspects of brain function. Read more about this study

Who is it for?
Ages 60 years and older
Conditions the study is for
Opioid-Free Anesthesia, POCD, Recovery Quality
What is being tested?
Opioid-free Analgesics and Opioid group
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
No sites listed yet
Study dates
1 Oct 2027to 31 Oct 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

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 60 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Elderly patients to undergo elective non-cardiac surgery
  • ASA grade I or III;
  • volunteered in this trial and signed informed consent;
  • age 60 years;
  • BMI 18-30kg / m2.

Who cannot join

  • Chronic pain;
  • severe liver dysfunction (total bilirubin 2 mg dl-1);
  • severe renal dysfunction (glomerular filtration rate 60ml min-1 1.73m-2);
  • preoperative heart rate <50 beats / min, sick sinus syndrome, severe heart block;
  • dementia or significant neurological disease (such as stroke, epilepsy, intracranial tumor, Parkinson disease, etc);
  • history of alcohol or drug abuse;
Show all 9Show fewer
  • preoperative or PSQI score 7 or sleep disturbance;
  • Cannot cooperate with the scale survey
  • Allergic to the trial drug

About this study

Postoperative cognitive dysfunction (POCD)is a common well disorder of the central nervous system after surgery, mainly manifested by impaired memory, spirit, language ability or other aspects of brain function. POCD, which often occurs in elderly patients over 65 years, The recent phase is recommended to be changed to perioperative neurocognitive impairment ( PND), The PND is used to describe the cognitive function changes that occur before and within 1 year after surgery, Based on the time of disease onset, It can be divided into neurocognitive impairment existing before surgery, postoperative delusion (POD) occurring hours to days after surgery, neurocognitive recovery delay (DNR) within 30 days after surgery, and postoperative neurocognitive impairment occurring weeks to months after surgery (POND). With the acceleration of the aging process of Chinese social population, the frequency of surgical treatment for elderly inpatients has also increased, and the elderly patients have postoperative sleep disorders, and POCD is relatively common. Surgical patients after surgical trauma, the body inflammation, sympathetic excitation and endocrine disorders, make postoperative sleep structure or pattern change, often lead to postoperative sleep disorders (PSD) , the main performance for patients with postoperative complaint difficult to enter and maintain sleep, frequent nightmares, total sleep quantity and quality reduction, etc. PSD is not only the most common manifestation of postoperative brain dysfunction, but also an important risk factor for inducing postoperative fatigue, postoperative hyperalgesia, metabolic dysfunction, and cardiovascular and cerebrovascular diseases. Moreover, it is considered to promote the development of postoperative delusion. At present, the common mode of general anesthesia is still mainly opioids, and opioids are an important part of general anesthesia and perioperative analgesia. Perioperative use of opioids is not only associated with adverse effects such as postoperative nausea and vomiting, excessive sedation, and ileus, but also leads to the occurrence of postoperative hypoxemia, hyperalgesia and postoperative chronic pain, and cognitive impairment. Therefore, the Association of Accelerated Rehabilitation Surgery indicates that the use of a multimodal analgesic regimen during the perioperative period reduces pain and reduces opioid-related adverse effects, and that opioid-free anesthesia ( OFA) is used in clinical work. At present, most clinical studies of OFA focus on adults aged 18-65 or 18 years old, and few studies focus OFA solely on the elderly population to observe its application effect. Therefore, it is necessary to conduct clinical studies to observe postoperative recovery in elderly patients with different types of anesthetics, investigate the incidence and severity of POCD, and determine the efficacy and safety of each anesthetic agent.

Being tested
Opioid-free Analgesics, Opioid group
Medical subject headings
Sleep Initiation and Maintenance Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Opioid-free AnalgesicsDrug

    opioid free group: After infusion of a loading dose of dexmedetomidine, intravenous midazolam 2mg, propofol 2mg kg-1, esketamine 0.5 mg kg-1, rocuronium 0.6-1mg kg-1, and 3min after endotracheal intubation. Intravenous continuous infusion of propofol, esketamine and dexmedetomidine hydrochloride mixture (esketamine 50mg + dexmedetomidine hydrochloride 150 ug + 0.9% saline 50ml in the same 50ml syringe) 0.1ml kg-1 h-1-0.2 ml kg-1 h-1 (equivalent to esketamine 0.1-0.2mg kg-1 h-1; Dexmedetomidine hydrochloride 0.3-0.6 μ g kg-1 h-1) maintains a BIS value between 40-60, 10-20mg / time was added as appropriate.

  • Opioid groupDrug

    Intravenous midazolam 2mg, propofol 2mg kg-1, sufentanyl 0.3-0.5 μ g kg-1, rocuronium 0.6-1mg kg-1,3min before endotracheal intubation. After successful endotracheal intubation, continuous intravenous infusion of propofol and remifentanil was started to maintain BIS values between 40-60, and rocuronium 10-20mg / time as appropriate. After the start of surgery, 10-20 μ g of sufentanil was added according to blood pressure and heart rate. At the end of the operation, 5mg and 50mg were injected before the end of the operation, and propofol and remifentanil were stopped at the end of the operation

Study groups in NCT06493396
Study groupRoleWhat they receive
Opioid-free groupExperimentalNot described
Receives: Drug: Opioid-free Analgesics
Opioid groupActive comparatorNot described
Receives: Drug: Opioid group

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 15-item recovery quality scale score 24 hours before surgery

    The QoR-15 scale is a global measure of postoperative recovery, with scores ranging from 0 (extremely poor QoR) to 150 (excellent QoR). QoR-15 has become the most widely reported indicator for the evaluation of postoperative life treatment in patients. Using wherever possible QoR-15 item scores on postoperative day 3, QoR-15 with very good validity, and good reliability, responsiveness and clinical acceptability, these data suggest that QoR-15 is an excellent patient-centered measure of postoperative QoR. Patient Acceptable symptom status describes the lowest absolute score considered by the patient to represent a healthy or good status health scale. A QoR-15 score of 118 or more indicates a good postoperative recovery

    Measured: 24 hours before surgery

  2. 15-item recovery quality scale score 24 hours after surgery

    The QoR-15 scale is a global measure of postoperative recovery, with scores ranging from 0 (extremely poor QoR) to 150 (excellent QoR). QoR-15 has become the most widely reported indicator for the evaluation of postoperative life treatment in patients. Using wherever possible QoR-15 item scores on postoperative day 3, QoR-15 with very good validity, and good reliability, responsiveness and clinical acceptability, these data suggest that QoR-15 is an excellent patient-centered measure of postoperative QoR. Patient Acceptable symptom status describes the lowest absolute score considered by the patient to represent a healthy or good status health scale. A QoR-15 score of 118 or more indicates a good postoperative recovery

    Measured: 24 hours after surgery

  3. 15-item recovery quality scale score 48 hours after surgery

    The QoR-15 scale is a global measure of postoperative recovery, with scores ranging from 0 (extremely poor QoR) to 150 (excellent QoR). QoR-15 has become the most widely reported indicator for the evaluation of postoperative life treatment in patients. Using wherever possible QoR-15 item scores on postoperative day 3, QoR-15 with very good validity, and good reliability, responsiveness and clinical acceptability, these data suggest that QoR-15 is an excellent patient-centered measure of postoperative QoR. Patient Acceptable symptom status describes the lowest absolute score considered by the patient to represent a healthy or good status health scale. A QoR-15 score of 118 or more indicates a good postoperative recovery

    Measured: 48 hours after surgery

Secondary outcomes (11)
  1. Pittsburgh Sleep Quality Index,PSQI

    The PSQI scale consists of seven aspects, including time to sleep, hypnotic drugs, sleep time, daytime dysfunction, sleep quality, sleep efficiency, and sleep disorders, with a total score of 0 to 21, which is generally considered in China Score 7 means the presence of sleep disturbance, the higher the score indicates more severe sleep disturbance]; due to PSQI The simplicity of the scale has good reliability and validity, and the results of polysomnography and EEG exist larger Guan Xing, which has become the most widely used scale in sleep research at home and abroad

    Measured: one night before surgery

  2. Pittsburgh Sleep Quality Index,PSQI

    The PSQI scale consists of seven aspects, including time to sleep, hypnotic drugs, sleep time, daytime dysfunction, sleep quality, sleep efficiency, and sleep disorders, with a total score of 0 to 21, which is generally considered in China Score 7 means the presence of sleep disturbance, the higher the score indicates more severe sleep disturbance]; due to PSQI The simplicity of the scale has good reliability and validity, and the results of polysomnography and EEG exist larger Guan Xing, which has become the most widely used scale in sleep research at home and abroad

    Measured: first night after surgery

  3. Pittsburgh Sleep Quality Index,PSQI

    The PSQI scale consists of seven aspects, including time to sleep, hypnotic drugs, sleep time, daytime dysfunction, sleep quality, sleep efficiency, and sleep disorders, with a total score of 0 to 21, which is generally considered in China Score 7 means the presence of sleep disturbance, the higher the score indicates more severe sleep disturbance]; due to PSQI The simplicity of the scale has good reliability and validity, and the results of polysomnography and EEG exist larger Guan Xing, which has become the most widely used scale in sleep research at home and abroad

    Measured: the second night after surgery

  4. Pittsburgh Sleep Quality Index,PSQI

    The PSQI scale consists of seven aspects, including time to sleep, hypnotic drugs, sleep time, daytime dysfunction, sleep quality, sleep efficiency, and sleep disorders, with a total score of 0 to 21, which is generally considered in China Score 7 means the presence of sleep disturbance, the higher the score indicates more severe sleep disturbance]; due to PSQI The simplicity of the scale has good reliability and validity, and the results of polysomnography and EEG exist larger Guan Xing, which has become the most widely used scale in sleep research at home and abroad

    Measured: one week after surgery

  5. Rhodes Index of Nausea and Vomiting

    Rhodes Index of Nausea, Vomiting, and Retching, an 8-item questionnaire, to measure the incidence and severity of nausea, vomiting, and retching At each timepoint, a total Rhodes score was calculated from the sum of the 8 RINVR questions. Total Rhodes scores were compared at 6 different timepoints as well as overall across all 6 time points. record Nausea and vomiting, the Rhodes index score. Score 0: No symptoms of nausea, vomiting or retching

    • 1-8 points: Mild symptoms
    • 9-16 points: Moderate symptoms
    • 17-24 points: Severe symptoms
    • 25 points and above: Extremely severe symptoms, where the patient's daily activities and eating are completely disrupted

    Measured: one day before surgery

  6. Rhodes Index of Nausea and Vomiting

    Rhodes Index of Nausea, Vomiting, and Retching, an 8-item questionnaire, to measure the incidence and severity of nausea, vomiting, and retching At each timepoint, a total Rhodes score was calculated from the sum of the 8 RINVR questions. Total Rhodes scores were compared at 6 different timepoints as well as overall across all 6 time points. record Nausea and vomiting, the Rhodes index score. Score 0: No symptoms of nausea, vomiting or retching

    • 1-8 points: Mild symptoms
    • 9-16 points: Moderate symptoms
    • 17-24 points: Severe symptoms
    • 25 points and above: Extremely severe symptoms, where the patient's daily activities and eating are completely disrupted

    Measured: 6,24,48 hours after surgery

  7. Ramsay score

    Total score: 1 to 6,1 indicates insufficient sedation and restlessness; 2 indicates quiet and cooperation; 3 indicates drowsiness and response to commands; 4 indicates shallow sleep and quick response to strong acoustic stimulation; 5 means slow to sleep and response to strong acoustic stimulation; 6 indicates too deep calm and difficult to wake up Score 7 means the presence of sleep disturbance, the higher the score indicates more severe sleep disturbance]; due to PSQI The simplicity of the scale has good reliability and validity, and the results of polysomnography and EEG are large

    Measured: 6, 24, 48 hours after surgery

  8. visual analgesia score

    The total score is 0 to 10,0 indicates no pain, and 10 indicates the most severe play ache

    Measured: 6, 24, 48 hours after surgery

  9. The Mini-Cog cognitive score

    0 points: 3 words can not remember one, as dementia. 1~2 points: can remember 1~2 of 3 words, correct drawing clock test (CDT), normal cognitive function; incorrect CDT, and cognitive function deficit. 3 points: can remember 3 words, not fixed as dementia

    Measured: first night before surgery

  10. The Mini-Cog cognitive score

    0 points: 3 words can not remember one, as dementia. 1~2 points: can remember 1~2 of 3 words, correct drawing clock test (CDT), normal cognitive function; incorrect CDT, and cognitive function deficit. 3 points: can remember 3 words, not fixed as dementia

    Measured: first day,second day and one week after surgery

  11. Number of salvage analgesia used within 48 h after surgery

    record number of salvage analgesia used within 48 h after surgery

    Measured: 48 h after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jul 2024
  2. Study start1 Oct 2027 (estimated)
  3. Primary completion31 Oct 2028 (estimated)
  4. Study completion31 Oct 2028 (estimated)

Resources

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
88 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06493396
Sponsor's protocol ID
opioid-free in elderly
Status last verified
Oct 2026
First submitted
2 Jul 2024
Last updated
20 Oct 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing Opioid-free Analgesics and Opioid group in people with Opioid-Free Anesthesia and POCD, run by Beijing Friendship Hospital.

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 5 inclusion and 9 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: opening soon, as of the sponsor's last update on 20 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

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?

This study is still under way. Results are not available in the source record yet.

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?

15-item recovery quality scale score 24 hours before surgery (time frame: 24 hours before 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 20 Oct 2026.

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