Study Objectives This study aims to investigate the effects of preoperative stellate ganglion block and intraoperative intravenous dexmedetomidine on postoperative sleep disturbance in patients undergoing laparoscopic gynecologic surgery, with the goals of reducing pain and postoperative adverse reactions and identifying an effective, safe, economical, and broadly applicable intervention strategy that may facilitate emergence from anesthesia, accelerate postoperative recovery, shorten the length of hospital stay, and reduce hospitalization costs.
This trial aims to determine whether preoperative stellate ganglion block (SGB) and intraoperative intravenous dexmedetomidine (DEX) can improve postoperative sleep quality in patients undergoing laparoscopic gynecologic surgery, and whether the combination of these two interventions provides an interaction effect or additional ben
Patients with American Society of Anesthesiologists (ASA) physical status I-III;
Age 18-75 years;
Scheduled to undergo laparoscopic gynecologic surgery (laparoscopic hysterectomy or laparoscopic surgery for uterine fibroids).
Preoperative sore throat or hoarseness;
History of upper respiratory tract infection within the previous 2 weeks;
Anticipated difficult tracheal intubation (Mallampati class III or IV, potential facial deformity, mouth opening <3 finger breadths, etc.);
Severe preoperative cardiac, hepatic, renal, or other organ dysfunction;
Parallel
DEX 0.2 μg/kg/h.
DrugDexmedetomidine is administered by intravenous infusion after induction of anesthesia without a loading dose, at an infusion rate of 0.2μg·kg-¹·h-¹, and continued until the end of surgery.
SGB
Procedure/SurgeryStellate ganglion block (SGB) is performed 15 min after induction of anesthesia by an anesthesiologist experienced in ultrasound-guided regional anesthesia, who is aware of the patient's group assignment. The patient is placed in the supine position with the neck slightly extended and rotated to the contralateral side. Under sterile conditions, a high-frequency linear-array ultrasound transducer is used to scan the anterior neck transversely at the C6 level, sequentially identifying the common carotid artery, internal jugular vein, thyroid gland, esophagus, C6 transverse process and anterior tubercle, longus colli muscle, and surrounding vascular structures. In the SGB group, an in-plane needle approach is used under real-time ultrasound guidance. After the needle tip reaches the fascial plane anterior to the longus colli muscle and negative aspiration for blood is confirmed, 5 mL of 0.375% ropivacaine is injected slowly. Spread of the local anesthetic along the surface of the longus
0.9% Sodium Chloride (Placebo)
DrugAn equal volume of 0.9% sodium chloride solution is administered by intravenous infusion after induction of anesthesia as a placebo for dexmedetomidine and continued until the end of surgery.
Sham Stellate Ganglion Block
Procedure/SurgeryParticipants are placed in the same position as those receiving the stellate ganglion block, and the ultrasound probe is placed on the neck in an identical manner to simulate the procedure. No needle puncture or drug injection is performed.
St. Mary's Hospital Sleep Questionnaire Score 1 Day Before Surgery
Subjective sleep quality is assessed using the St. Mary's Hospital Sleep Questionnaire (SMHSQ). The total score ranges from 11 to 37, with higher scores indicating poorer sleep quality.
Total Sleep Time 1 Day Before Surgery
Total sleep time (TST), expressed in minutes, is objectively measured using a Fitbit Charge 6 wrist-worn device.
Wake After Sleep Onset 1 Day Before Surgery
Wake after sleep onset is the total duration of wakefulness after initial sleep onset during the assessed sleep period, measured in minutes using a Fitbit Charge 6 wrist-worn device.
Sleep Efficiency 1 Day Before Surgery
Sleep efficiency is calculated as total sleep time (TST) divided by the sum of total sleep time and wake after sleep onset (WASO), multiplied by 100. TST and WASO are obtained using a Fitbit Charge 6 wrist-worn device. Values range from 0% to 100%, with higher values indicating a greater proportion of the assessed sleep period spent asleep.
Postoperative Pain Intensity at 6 Hours
Postoperative pain intensity is assessed using the Visual Analog Scale. Scores range from 0 to 10, with 0 indicating no pain and 10 indicating the worst imaginable pain. Higher scores indicate greater pain intensity.
Postoperative Pain Intensity at 24 Hours
Postoperative pain intensity is assessed using the Visual Analog Scale. Scores range from 0 to 10, with 0 indicating no pain and 10 indicating the worst imaginable pain. Higher scores indicate greater pain intensity.
Postoperative Pain Intensity at 48 Hours
Postoperative pain intensity is assessed using the Visual Analog Scale. Scores range from 0 to 10, with 0 indicating no pain and 10 indicating the worst imaginable pain. Higher scores indicate greater pain intensity.
Total Intraoperative Sufentanil Consumption
The cumulative dose of sufentanil administered to each participant from induction of anesthesia to the end of surgery is recorded in micrograms.
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Catherin Zhang
Lead sponsor
The Second People's Hospital of Huai'an
Sponsor institution
