Esketamine on Postoperative Sleep Disturbance of Patients Undergoing Spinal Surgery

Beijing Tiantan Hospital156 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

156

Conditions

Esketamine Sleep Disturbance Spinal Surgery

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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 surgery

Secondary Outcomes

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 surgery

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 surgery

dosage of analgesics

The analgesic consumption(PCIA) and supplemental analgesics within 72h will be recorded.

Time frame: within 72 hours after surgery

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.