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Comparison of Postoperative Pain Application of Alfentanil or Remifentanil in TIVA

Comparison of Postoperative Pain Application of Alfentanil or Remifentanil in TIVA Undergoing Functional Endoscopic Sinus Surgery

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05344911
Acronym
TIVA
Enrollment
130
Registered
2022-04-25
Start date
2022-04-29
Completion date
2022-08-30
Last updated
2023-01-19

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

Conditions

Postoperative Pain

Keywords

functional endoscopic sinus surgery, postoperative pain, afentanil or remifentanil

Brief summary

Total intravenous anesthesia (TIVA) is maintained by intermittent or continuous combined intravenous injection of a variety of short-acting intravenous anesthetics, which can provide safe and rapid induction, maintenance and termination of general anesthesia. It has a slight effect on respiration and circulation, strong controllability, short anesthetic recovery time, reduced postoperative nausea and vomiting (PONV) and quick discharge time, so it has been widely used in clinic. Functional endoscopic sinus surgery is a common method for the treatment of sinusitis and other diseases. The trauma of this operation is less. The use of TIVA during the operation can reduce the bleeding in the surgical field and is beneficial to the recovery of patients. The combination of propofol and remifentanil is the most common in TIVA because of its fast pharmacokinetics and short half-life. However, the disadvantage of remifentanil is the lack of residual analgesic effect after termination of continuous infusion. As postoperative nasal packing can still bring postoperative pain, patients with severe discomfort caused by pain will have unexpected conditions such as surgical incision cracking and bleeding, which will affect the effect of operation and rehabilitation. Afentanil is another opioid drug with short effect and strong analgesic effect. Previous studies have shown that remifentanil-based TIVA has slightly higher postoperative pain and early use of analgesics than TIVA in discectomy. Because the effect of TIVA using Afentanil or remifentanil on postoperative pain in functional nasal endoscopic surgery is not clear, this study intends to observe the effect of TIVA on postoperative pain in patients undergoing functional nasal endoscopic surgery under general anesthesia, so as to optimize the clinical anesthetic scheme of this kind of minimally invasive surgery and provide clinical reference.

Detailed description

This study intends to observe the effect of TIVA using afentanil or remifentanil on postoperative pain in patients undergoing functional nasal endoscopic surgery under general anesthesia. Main indicators: VAS score at 30 min after operation. Secondary indicators: VAS score of 60 min after operation. VAS score of 24h after operation. Number of cases of postoperative use of analgesics . Number of cases of postoperative adverse reactions.

Interventions

DRUGPropofol combined with alfentanil

Anesthesia induction: midazolam 0.02 mg/kg, propofol(TCI) 3 μ g/mL, alfentanil 20 μ g/kg and rocuronium 0.6 mg/kg . Anesthesia maintenance: target-controlled infusion of propofol combined with alfentanil(0.5-2ug/kg/min)

DRUGPropofol combined with remifentanil

Anesthesia induction: midazolam 0.02 mg/kg, propofol(TCI) 3 μ g/mL, remifentanil 1μ g/kg and rocuronium 0.6 mg/kg . Anesthesia maintenance: target-controlled infusion of propofol combined with remifentanil(0.1-0.3ug/kg/min)

Sponsors

Xijing Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

* Age 18-65 years old * ASA Ⅰ-Ⅲ * patients undergoing functional endoscopic sinus surgery under general anesthesia.

Exclusion criteria

* Significant hypertension (diastolic blood pressure \> 100mmHg) or hypotension (systolic . blood pressure \< 100mmHg). * severe mental, cardiovascular, kidney or liver disease. * previous history of alcohol or drug abuse. * long-term use of painkillers before operation. * contraindications for any drugs used in the study.

Design outcomes

Primary

MeasureTime frameDescription
VAS scorePostoperative 30minutesthe digital rating scale (VAS) uses a number between 0 and 10 to indicate that there is no pain; a score of 1-3 means that a slight pain can be tolerated; a score of 4-6 indicates that it is bearable if it does not affect sleep; a score of 7-10 indicates that it is becoming more and more painful and unbearable, affecting appetite and sleep

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026