Esketamine, Sleep Disturbance, Spinal Surgery
Conditions
Brief summary
The goal of this clinical trial is to learn about the effect of intraoperative esketamine infusion on postoperative sleep disturbance(PSD) of patients undergoing spinal surgery. The main aims to answer are: * To explore the effect of intraoperative infusion of esketamine on the incidence of postoperative sleep disturbance and sleep quality in patients undergoing spinal surgery. * To explore the effect of intraoperative infusion of esketamine on postoperative pain, anxiety and depression ; Participants will be patients undergoing spinal surgery with general anesthesia at Beijing Tiantan Hospital. 0.3mg/kg/h esketamine or saline will be infused during surgery . The incidence of sleep disturbance , sleep quality, pain scores, hospital anxiety and depression scores and perioperative adverse events after surgery will be investigated.
Interventions
DRUGEsketamine
Esketamine ( 50mg, dissolved in 50ml normal saline ) will be infused at a speed of 0.3mg / kg / h during surgery .
DRUGsaline
Saline will be infused at a speed of 0.3mg / kg / h during surgery .
Sponsors
Beijing Tiantan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* 18-65 years old, * American Society of Anesthesiologist (ASA) Physical Status classification I to III ; * Patients scheduled to undergo elective spinal surgery under general anesthesia; * Signed informed consent ;
Exclusion criteria
* BMI \> 35kg / m2 ; * Severe lesions of important organs and systems ; * The estimated duration of surgery is more than 4 hours * Patients who were retained tracheal intubation or admitted to intensive care unit (ICU) postoperatively. * History of adverse reactions or contraindications to ketamine and esketamine ; * Cognitive dysfunction, communication disorders ; * Refused to participate in this study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The incidence of postoperative sleep disturbance(PSD) in patients undergoing spinal surgery | during the first three days after surgery | It will be evaluated by Athens Insomnia Scale (AIS) on the morning(8-10 am) of postoperative days 1-3, a score of 6 or higher will be defined as PSD. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| objective sleep quality(total sleep time) of patients with spinal surgery assesssed by the sleep monitoring equipment. | on the postoperative day 1 and postoperative day 3 after surgery | It will be evaluated by an sleep monitoring equipment which can record total sleep time in hour. |
| The pain scores | within 72hours after surgery | Postoperative pain at rest and movement will be evaluated on the morning(8-10 am) of postoperative days 1-3 using NRS.0 indicating no pain, 10 indicating worst pain imaginable. |
| dosage of analgesics | within 72 hours after surgery | The analgesic consumption(PCIA) and supplemental analgesics within 72h will be recorded. |
| Postoperative hospital anxiety and depression scale ( HADS ) score. | on the postoperative day 1 and postoperative day 3 after surgery | Postoperative anxiety and depression scores will be measured by the Hospital Anxiety and Depression Scale, on the morning(8-10 am) of postoperative days (PODs) 1 and 3 , a score of 8 points or higher will be diagnosed as depression or anxiety. |
Other
| Measure | Time frame | Description |
|---|---|---|
| The incidence of all drug-related adverse events | within 72hours after surgery | All drug-related adverse events including bradycardia, hypotension, tachycardia, hypertension, arrhythmia, nystagmus, hypersalivation, euphoria, emergence agitation, hallucinations, dreaminess and nightmares during surgery or before discharge.etc.Patients will be followed up for 3 days consecutively(at 8-10am). |
Countries
China
Outcome results
None listed