Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing Tiantan Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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 ;
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Esketamine
DrugEsketamine ( 50mg, dissolved in 50ml normal saline ) will be infused at a speed of 0.3mg / kg / h during surgery .
saline
DrugSaline will be infused at a speed of 0.3mg / kg / h during surgery .
Treatment groups
156 Participants
are divided into 2 treatment groupsGroup A: esketamineExperimental treatment 1 intervention
Group B: salinePlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
The incidence of postoperative sleep disturbance(PSD) in patients undergoing spinal 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.
Time frame
during the first three days after surgerySecondary outcomes
1
objective sleep quality(total sleep time) of patients with spinal surgery assesssed by the sleep monitoring equipment.
It will be evaluated by an sleep monitoring equipment which can record total sleep time in hour.
Time frame
on the postoperative day 1 and postoperative day 3 after surgery2
The pain scores
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.
Time frame
within 72hours after surgery3
dosage of analgesics
The analgesic consumption(PCIA) and supplemental analgesics within 72h will be recorded.
Time frame
within 72 hours after surgery4
Postoperative hospital anxiety and depression scale ( HADS ) score.
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.
Time frame
on the postoperative day 1 and postoperative day 3 after surgeryOther outcomes
1
The incidence of all drug-related adverse events
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).
Time frame
within 72hours after surgerySponsors and contacts
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Source ClinicalTrials.gov