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Analysis of the effectiveness of nociceptive index in monitoring nociceptive stimulation during induction of general anesthesia

Analysis of the effectiveness of nociceptive index in monitoring nociceptive stimulation during induction of general anesthesia

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100050369
Enrollment
Unknown
Registered
2021-08-26
Start date
2021-10-01
Completion date
Unknown
Last updated
2022-04-25

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

Conditions

Pain

Interventions

Group A:Remifentanil TCI: 2 ng/ml, and tonic stimulation
Group B:Remifentanil TCI: 4 ng/ml, and tonic stimulation

Sponsors

Department of Anesthesiology, Shenzhen People's Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Subjects voluntarily sign the informed consent of this study; 2. Age between 18 and 65 years old, gender is not limited, weight kg=(height cm-100)±15%; 3. ASA I and II; 4. For surgical patients who need elective surgery under general anesthesia and need endotracheal intubation, surgery is required for non-emergency inpatients who have received appropriate preoperative preparation, with 1-2 hours of non-craniotomy and non-thoracotomy;Patients undergoing elective general anesthesia and requiring endotracheal intubation; 5. Subjects can follow the drug dosage and visit plan; 6. The systolic blood pressure (SBP) was 90-140 mmHg, and the diastolic blood pressure (DBP) was less than 90 mmHg; Body temperature = 100 g/L), platelet (>=75x10^9/L), white blood cell (3-15 x1 0^9/L); (2) Urine routine: urine protein (= 32 g/L; (4) Renal function: BUN and Cr were within the normal reference range; (5) Blood glucose: fasting blood glucose (FPG, 3.0-8.9 mmol/L or 55-160 mg/dL); (6) Blood lipid: total cholesterol (TC < 7.75 mmol/L or 300 mg/dL) and triglyceride (TG < 3.42 mmol/L or 300 mg/dL); (7) Electrolytes: Na^+ (130 ~ 150 mmol/L), K^+ (3.0 ~ 5.5 mmol/L), Ca^2+ (2.0 ~ 2.9 mmol/L).

Exclusion criteria

Exclusion criteria: 1. Those who are judged by the anesthesiologist to be unsuitable to participate in this trial; 2. Chronic pain with long-term use of analgesics, psychiatric drugs (including opioids, NSAIDs, sedatives, antidepressants), alcohol abuse; 3. Abnormal surgical anesthesia recovery history; 4. Suffer from esophageal reflux disease; 5. Sedatives, antiemetic drugs and antipruritic drugs were used 24 hours before surgery; 6. Difficult intubation is expected; 7. Have a history of opioid allergy; 8. Take monoamine oxidase inhibitors or antidepressants within 15 days; 9. Shock patients; 10. COPD patients; 11. Pregnant or parturient women; 12. Participated in other drug trials within three months; 13. Sponsors or researchers directly involved in the trial or their family members; 14. The researcher believes that there is any reason why the candidate cannot be selected.

Design outcomes

Primary

MeasureTime frame
Nociceptive index;Blood pressure;Heart rate;

Secondary

MeasureTime frame
Bispectral index;SPO2;

Countries

China

Contacts

Public ContactWu Chaoran

Department of Anesthesiology, Shenzhen People's Hospital

chaoranwu@126.com+86 18100282848

Outcome results

None listed

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