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Comparison of Postoperative Pain Application of Alfentanil or Remifentanil in TIVA

A

Air Force Military Medical University of People's Liberation Army

Status and phase

Completed
Phase 4

Conditions

Postoperative Pain

Treatments

Drug: Propofol combined with remifentanil
Drug: Propofol combined with alfentanil

Study type

Interventional

Funder types

Other

Identifiers

NCT05344911
xijing2022-0410

Details and patient eligibility

About

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.

Full 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.

Enrollment

130 patients

Sex

All

Ages

18 to 65 years old

Volunteers

Accepts Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

130 participants in 2 patient groups

remifentanil
Active Comparator group
Description:
Anesthesia maintenance:target-controlled infusion of propofol combined with remifentanil)
Treatment:
Drug: Propofol combined with remifentanil
alfentanil
Experimental group
Description:
Anesthesia maintenance:target-controlled infusion of propofol combined with afentanil
Treatment:
Drug: Propofol combined with alfentanil

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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