Clinical Trials Directory

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UnknownNCT04295109

Comparison of the Effects of Fentanyl, Oxycodone, Butorphanol on Gastrointestinal Function

Comparison of the Effects of Fentanyl, Oxycodone, Butorphanol on Gastrointestinal Function in Patients Undergoing Laparoscopic Hysterectomy: a Double-blind, a Randomized Controlled Trial

Status
Unknown
Phase
N/A
Study type
Interventional
Enrollment
105 (estimated)
Sponsor
The First Affiliated Hospital with Nanjing Medical University · Academic / Other
Sex
Female
Age
40 Years – 65 Years
Healthy volunteers
Accepted

Summary

Postoperative ileus (POI) is a transient loss of coordinated peristalsis precipitated by surgery and exacerbated by opioid pain medication.So,how to provide patients with ideal analgesia without affecting the recovery of postoperative gastrointestinal function?This was a prospective randomized controlled study. A total of 105 patients who were scheduled for laparoscopic hysterectomy were randomly selected from The First Affiliated Hospital with Nanjing Medical University by random number table. These patients were randomly divided into three groups: fentanyl(F) group, oxycodone(O) group and butorphanol(B) group.

Detailed description

Background: Patients often experience pain after gynecological laparoscopy. However, the use of opioid analgesia after surgery may increase the incidence of postoperative ileus (POI). Postoperative ileus (POI) is a common surgical emergency after a surgical procedure, leading to infection and intestinal adhesions, which can extend hospitalization and increase readmission rates, and consequently increasing healthcare costs. How to provide patients with ideal analgesia without affecting the recovery of postoperative gastrointestinal function? There is no guideline which has been troubling clinical anesthesiologists. Aims: To observe the effects of fentanyl, oxycodone, Butorphanol on the recovery of gastrointestinal function after laparoscopic hysterectomy. Methods: A total of 105 patients undergoing laparoscopic hysterectomy were randomly divided to three groups: fentanyl group(group F), butorphanol group(group B), or oxycodone group(group O). The primary outcome measures were postoperative time to first anal exhaust the total analgesic doses in PCIA,effective bolus times. Patients were also assessed for pain with a visual analogue scale (VAS), the cumulative PCIA dose, adverse effects (Nausea,vomiting, bradycardia, respiratory depression and pruritus), sedation level at 4, 12, 24, and 48 hours postoperatively, and satisfaction during the postoperative 48 hours and postoperative hospitalization days.

Conditions

Interventions

TypeNameDescription
DRUGthe drug of intravenous patient-controlled analgesiaAt present, opioids are most widely used in postoperative analgesia. This study aims to use different opioid receptor agonists---fentanyl, oxycodone and butorphanol for analgesia after laparoscopic hysterectomy.Compare the recovery of gastrointestinal function after operation.

Timeline

Start date
2020-03-02
Primary completion
2020-07-31
Completion
2020-07-31
First posted
2020-03-04
Last updated
2020-04-24

Locations

1 site across 1 country: China

Source: ClinicalTrials.gov record NCT04295109. Inclusion in this directory is not an endorsement.