Clinical trial NCT05344911: Comparison of Postoperative Pain Application of Alfentanil or Remifentanil in TIVA
Official title: Comparison of Postoperative Pain Application of Alfentanil or Remifentanil in TIVA Undergoing Functional Endoscopic Sinus Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Postoperative Pain
Keywords: functional endoscopic sinus surgery
postoperative pain
afentanil or remifentanil
Lead sponsor: Xijing Hospital
Sponsor class: OTHER
First posted: 2022-04-25
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: VAS score
timeFrame: Postoperative 30minutes
Secondary outcomes:
Other outcomes:
Locations:
city: XIan
country: China
facility: YANLI
state: Shanxi
Study officials:
affiliation: The First Affiliated Hospital of the Air Force Medical Universtiy
name: Yan Jia
role: PRINCIPAL_INVESTIGATOR
References:
citation: Doganay G, Ekmekci P, Kazbek BK, Yilmaz H, Erkan G, Tuzuner F. Effects of alfentanil or fentanyl added to propofol for sedation in colonoscopy on cognitive functions: Randomized controlled trial. Turk J Gastroenterol. 2017 Nov;28(6):453-459. doi: 10.5152/tjg.2017.16489. Epub 2017 Sep 19.