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NOX index guidied administration of remifentanil in gynecological laparoscopic surgery: a randomized controlled trial

NOX index guidied administration of remifentanil in gynecological laparoscopic surgery: a randomized controlled trial

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2300071593
Enrollment
Unknown
Registered
2023-05-18
Start date
2023-11-01
Completion date
Unknown
Last updated
2023-11-27

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

Conditions

Gynecological laparoscopic surgery

Interventions

Intervention group:Nox-guided remifentanil in laparoscopic surgery:
standard of care:Remifentanil was used according to clinical experience

Sponsors

First People's Hospital of Changde city
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age greater than 18 but less than 65 years old; 2. ASA level I to III; 3. Selective laparoscopic appendage and/or hysterectomy surgery; 4. Expected surgical duration>1 hour; 5. Sign an informed consent form.

Exclusion criteria

Exclusion criteria: 1. NOX monitoring cannot be carried out (such as damage to the forehead skin); 2. History of central nervous system diseases and mental illnesses; 3. Preoperative use of chronic opioid drugs (defined as taking 60 milligrams of morphine equivalent daily for the past 3 months and lasting for more than 1 week); 4. Body mass index exceeding 28 kg/m2; 5. Patients who have implanted pacemakers.

Design outcomes

Primary

MeasureTime frame
The consumption of remifentanil during the surgery;Postoperative opioid consumption (morphine equivalents) in the PACU;

Secondary

MeasureTime frame
Percentage of time for the intraoperative NOX more than 50;The number of patients with hemodynamic instability;Wake-up time (Time between the end of remifentanil and extubation);NRS scores at rest and cough within 30 minutes of extubation and 24 hours, nausea and vomiting score and number of patients reporting respiratory depression (an oxygen saturation below 90%) and pruritus will also be collected within 30 minutes after extubation and 24 hours;The time it takes to request analgesia for the first time;Nonsteroidal anti-inflammatory drug (NSAID) consumption within 24 hours after surgery;

Countries

China

Contacts

Public ContactXiaoting Shi

First People's Hospital of Changde city

Shixiaotinghn@163.com+86 152 1121 9328

Outcome results

None listed

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