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The effect of sufentanil dosing on heart rate variability and postoperative nausea and vomiting in male and female patients undergoing thyroid cancer surgery: a randomized controlled clinical trial

The effect of sufentanil dosing on heart rate variability and postoperative nausea and vomiting in male and female patients undergoing thyroid cancer surgery: a randomized controlled clinical trial

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2500106026
Enrollment
Unknown
Registered
2025-07-16
Start date
2025-07-25
Completion date
Unknown
Last updated
2025-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sex differences in heart rate variability, postoperative nausea and vomiting

Interventions

High-dose sufentanil group (experimental group):0.5ug/kg sufentanil pushed at induction of anesthesia
Low-dose sufentanil group (control group):0.3ug/kg sufentanil pushed at induction of anesthesia

Sponsors

Qilu Hospital, Shandong University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Patients diagnosed with thyroid cancer; 2. Age 18-65 years old; 3.BMI:18-35kg/m^2; 4. American Society of Anesthesiologists (ASA) class I.-III; 5. Patients who intend to undergo radical thyroidectomy under general anesthesia.

Exclusion criteria

Exclusion criteria: 1. Those who have smoked, drunk, drunk coffee or had poor sleep recently; 2. Recent opioid users; 3. Those with severe respiratory diseases; 4. Patients with serious neurological and psychiatric diseases; 5. Those with diseases that affect autonomic nerve function and are poorly controlled; 6. Severe cardiopulmonary cerebrovascular or liver and kidney function impairment; 7. Mood disorders such as anxiety and depression before surgery; 8. Taking drugs that affect HRV (such as ß receptor blockers, antiarrhythmics, antidepressants, etc.); 9. Do not agree to participate in this study; 10. Other reasons why the investigator thinks it is not appropriate to participate in the trial.

Design outcomes

Primary

MeasureTime frame
Overall incidence of PONV at 24h postoperatively;Mean values of LF/HF and RMSSD between the start of anesthesia induction and the end of surgery;

Secondary

MeasureTime frame
Incidence of PONV in the immediate postoperative period, 0-6h, 6-24h;Use of remedial antiemetics in the 24h postoperative period;Visual analog scores of patient pain in the immediate, 6h, and 24h postoperative periods;Use of remedial analgesics in the 24h postoperative period;Hemodynamic parameters, including heart rate, diastolic and systolic blood pressure, and EEG bifrequency indices, at different points in time during the operation;Values of heart rate variability parameters such as low-frequency power (LF), high-frequency power (HF), low-frequency/high-frequency ratio (LF/HF), normalized high-frequency (HFnu), total power (TP), SDNN (standard deviation of normal RR intervals), and RMSSD (root-mean-square of the difference between adjacent RR intervals) at each time point;Intraoperative use of cardiovascular active drugs;Time of awakening;Time of extubation;Incidence of intraoperative hypertension, hypotension, bradycardia, tachycardia, and postoperative respiratory depression, chills, and other adverse effects in patients;

Countries

China

Contacts

Public ContactFeng Qi

Qilu Hospital, Shandong University

198962001111@sdu.edu.cn+86 185 6008 3756

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026