Uterine Fibroids (Leiomyoma), Adenomyosis of Uterus, Endometriosis, Endometrial Cancer, Cervical Cancer, Ovarian Cancer
Conditions
Brief summary
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
Interventions
DRUGDEX 0.2 μg/kg/h.
Dexmedetomidine 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.
PROCEDURESGB
Stellate 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
An 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.
PROCEDURESham Stellate Ganglion Block
Participants 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.
Sponsors
Catherin Zhang
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Patients with American Society of Anesthesiologists (ASA) physical status I-III; 2. Age 18-75 years; 3. Scheduled to undergo laparoscopic gynecologic surgery (laparoscopic hysterectomy or laparoscopic surgery for uterine fibroids).
Exclusion criteria
1. Preoperative sore throat or hoarseness; 2. History of upper respiratory tract infection within the previous 2 weeks; 3. Anticipated difficult tracheal intubation (Mallampati class III or IV, potential facial deformity, mouth opening \<3 finger breadths, etc.); 4. Severe preoperative cardiac, hepatic, renal, or other organ dysfunction; 5. Allergy to the local anesthetic used in the study, infection at the puncture site, or coagulation abnormalities; 6. Cognitive impairment, hearing impairment, language impairment, a history of psychiatric illness, or difficulty communicating or cooperating because of a psychiatric disorder.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| St. Mary's Hospital Sleep Questionnaire Score 1 Day Before Surgery | 1 day before surgery（ΡRE） | 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 | 1 day before surgery（PRE） | 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 | 1 day before surgery（PRE） | 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 | 1 day before surgery(PRE) | 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. |
| St. Mary's Hospital Sleep Questionnaire Score on Postoperative Day 1 | Postoperative Day 1（POD1） | 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 on Postoperative Day 1 | Postoperative day 1 | Total sleep time (TST), expressed in minutes, is objectively measured using a Fitbit Charge 6 wrist-worn device. |
| Wake After Sleep Onset on Postoperative Day 1 | Postoperative day 1（ΡOD1) | 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 on Postoperative Day 1 | Postoperative day 1(ΡOD1) | 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. |
| St. Mary's Hospital Sleep Questionnaire Score on Postoperative Day 2 | Postoperative Day 2（ΡOD2） | 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 on Postoperative Day 2 | Postoperative day 2 | Total sleep time (TST), expressed in minutes, is objectively measured using a Fitbit Charge 6 wrist-worn device. |
| Wake After Sleep Onset on Postoperative Day 2 | Postoperative day 2(POD2) | 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 on Postoperative Day 2 | Postoperative day 2(POD2) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative Pain Intensity at 6 Hours | 6 hours after surgery | 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 | 24 hours after surgery | 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 | 48 hours after surgery | 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 | From induction of anesthesia to the end of surgery | The cumulative dose of sufentanil administered to each participant from induction of anesthesia to the end of surgery is recorded in micrograms. |
| Total Intraoperative Remifentanil Consumption | From induction of anesthesia to the end of surgery | The cumulative dose of remifentanil administered to each participant from induction of anesthesia to the end of surgery is recorded in milligrams. |
| Number of Rescue Analgesia Administrations | From the end of surgery to 48 hours after surgery. | The total number of rescue analgesia administrations received by each participant during the first 48 hours after surgery is recorded. |
| Mean Arterial Pressure | Before induction of anesthesia (T0), at skin incision (T1), 30 minutes after the start of surgery (T2), 60 minutes after the start of surgery (T3), and at the end of surgery (T4). | Mean arterial pressure (MAP), expressed in mmHg, is recorded at five prespecified time points to assess perioperative hemodynamic changes. |
| Heart Rate | Before induction of anesthesia (T0), at skin incision (T1), 30 minutes after the start of surgery (T2), 60 minutes after the start of surgery (T3), and at the end of surgery (T4). | Heart rate (HR), expressed in beats per minute, is recorded at five prespecified time points to assess perioperative hemodynamic changes. |
| Number of Participants With Local Anesthetic Systemic Toxicity | From administration of the first study intervention to 48 hours after surgery. | The number of participants who experience local anesthetic systemic toxicity is recorded. Each participant is counted once, regardless of the number of episodes. |
| Number of Participants With Puncture-Site Hematoma | From administration of the first study intervention to 48 hours after surgery. | The number of participants who develop a puncture-site hematoma is recorded. Each participant is counted once, regardless of the number of episodes. |
| Number of Participants With Puncture-Site Infection | From administration of the first study intervention to 48 hours after surgery. | The number of participants who develop a puncture-site infection is recorded. Each participant is counted once, regardless of the number of episodes. |
| Number of Participants With Unintended Nerve Block | From administration of the first study intervention to 48 hours after surgery. | The number of participants who experience an unintended nerve block is recorded. Each participant is counted once, regardless of the number of episodes. |
| Number of Participants With Pneumothorax | From administration of the first study intervention to 48 hours after surgery. | The number of participants who develop pneumothorax is recorded. Each participant is counted once, regardless of the number of episodes. |
| Number of Participants With Bradycardia | From administration of the first study intervention to 48 hours after surgery. | The number of participants who experience bradycardia is recorded. Each participant is counted once, regardless of the number of episodes. |
| Number of Participants With Hypotension | From administration of the first study intervention to 48 hours after surgery. | The number of participants who experience hypotension is recorded. Each participant is counted once, regardless of the number of episodes. |
| Number of Participants With Hypoxemia | From administration of the first study intervention to 48 hours after surgery. | The number of participants who experience hypoxemia is recorded. Each participant is counted once, regardless of the number of episodes. |
| Number of Participants With Postoperative Nausea or Vomiting | From the end of surgery to 48 hours after surgery. | The number of participants who experience nausea, vomiting, or both during the first 48 hours after surgery is recorded. Each participant is counted once, regardless of the number of episodes or whether both symptoms occur. |
| Number of Participants With Postoperative Headache or Dizziness | From the end of surgery to 48 hours after surgery. | The number of participants who experience headache, dizziness, or both during the first 48 hours after surgery is recorded. Each participant is counted once, regardless of the number of episodes or whether both symptoms occur. |
| Number of Participants With Postoperative Nightmares or Excessive Dreaming | From the end of surgery to 48 hours after surgery. | The number of participants who report nightmares, excessive dreaming, or both during the first 48 hours after surgery is recorded. Each participant is counted once, regardless of the number of episodes or whether both symptoms occur. |
Countries
China
Contacts
CONTACTJun Wang
Outcome results
None listed