Effects of Esketamine Combined With Dexmedetomidine on Postoperative Sleep Quality
ConditionHip Fractures
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age65+
SponsorPeking University Shenzhen Hospital
About this trial
1. Eligible patients are randomly divided into experimental and control groups； 2. The experimental group is given esketamine combined with dexmedetomidine，while the control group is given normal saline； 3. The patients' sleep, pain, and cognition are followed up after surgery.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age≥ 65 years old;
Hip fracture surgery under neuraxial anesthesia;
Signed informed consent.
Disqualifiers
ASA classification≥ Class V;
Presence of neuraxial anesthesia contraindications: coagulation dysfunction, thrombocytopenia, neuraxial mass, puncture site infection, etc.;
Patients with contraindications to esketamine (such as allergies, intracranial aneurysms, hyperthyroidism and glaucoma);
Patients with contraindications to dexmedetomidine (allergies);
Trial design
Design model
Parallel
Treatments tested in this trial
Esketamine combined with dexmedetomidine
DrugAfter successful neuraxial anesthesia, 0.125mg/kg esketamine and 0.3ug/kg dexmedetomidine are diluted into 30ml of normal saline and continuously pumped for 20 minutes, then connected to a micropump: 15ug/kg/h esketamine 0.02ug/kg/h dexmedetomidine to 96ml saline, continuous amount: 2ml/h, continuous pumping for 48h.
Normal saline
DrugAfter successful neuraxial anesthesia, 30ml of normal saline was continuously pumped for 20 minutes, followed by a micropump: 96ml of saline, continuous amount: 2ml/h for 48h.
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: Esketamine combined with dexmedetomidine groupExperimental treatment 1 intervention
Group B: Normal saline groupPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
sleep quality
Richards-Campbell sleep questionnaire (RCSQ) score is used to assess the sleep quality, the total score is 100 point, the lowest score is 0 point, and the highest score is 100 point, with higher scores representing better sleep quality.
Time frame
the first postoperative nightSecondary outcomes
1
sleep quality
Richards-Campbell sleep questionnaire (RCSQ) score is used to assess the sleep quality, the total score is 100 point, the lowest score is 0 point, and the highest score is 100 point, with higher scores representing better sleep quality.
Time frame
the second postoperative night, third postoperative night2
Incidence of delirium
Incidence of delirium
Time frame
from the first to the fifth postoperative day3
pain score(FPS-R)
Wong-Baker facial expression pain scale revision (FPS-R) at rest and during activity, the lowest score is 0 point, and the highest score is 10 points, with higher scores indicating more severe pain.
Time frame
from the first day to the fifth postoperative day4
pain (NRS)
Numeric Rating Scale (NRS) at rest and during activity, the total score is 10 points, the lowest score is 0 point, and the highest score is 10 points, with higher scores indicating more severe pain.
Time frame
from the first day to the fifth postoperative daySponsors and contacts
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Source ClinicalTrials.gov