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

NCT04295109 | Unknown

• 1 other identifier: 2019-SR-476
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Cervix Neoplasms; Endometrial Cancer; Adenomyosis; Fibroid Uterus

Outcome Measures

Primary Outcomes (3)

• postoperative time to first anal exhaust

  Timing from the end of the operation

  From date of operation until the date of discharge from hospital or date of death from any cause, whichever came first, assessed up to 15 days

• the cumulative dose administered in the patient-controlled mode

  The cumulative dose administered in the patient-controlled mode during the initial 48 hours after the operation was measured

  From date of operation until the date of first documented progression of anal exhaust , assessed up to 48 hours

• effective bolus times

  The effective bolus times in the patient-controlled mode during the initial 48 hours after the operation was measured

  From date of operation until the date of first documented progression of anal exhaust , assessed up to 48 hours

Secondary Outcomes (14)

• pain score

  at 4 hours postoperatively

• pain score

  at 12 hours postoperatively

• pain score

  at 24 hours postoperatively

• pain score

  at 48 hours postoperatively

• Sedation score

  at 4 hours postoperatively

Study Arms (3)

Fentanyl group(group F)

ACTIVE COMPARATOR

Fentanyl citrate injection, specification: 10mL: 0.5mg / piece (production unit: niching chang rendu Pharmaceutical Co., Ltd., valid period: 48 months) For group F patients,0.5mg fentanyl was mixed with saline to a total volume of 100mL; continuous infusion was set to 2mL/h, a bolus dose of 3mL, and a lockout interval of 15 minutes

Drug: the drug of intravenous patient-controlled analgesia

Oxycodone group(group O)

EXPERIMENTAL

Oxycodone hydrochloride injection, specification: 1mL: 10mg / branch (production unit: HAMOL LIMITED, valid period: 60 months) For group O patients,30mg oxycodone was mixed with saline to a total volume of 100mL; continuous infusion was set to 2mL/h, a bolus dose of 3mL, and a lockout interval of 15 minutes

Drug: the drug of intravenous patient-controlled analgesia

Butorphanol group(group B)

EXPERIMENTAL

Butorphanol tartrate injection, specification: 1 mL: 1 mg / branch (production unit: Jiangsu henryi Pharmaceutical Co., Ltd., valid period: 24 months); For group B patients,10mg butorphanol was mixed with saline to a total volume of 100mL; continuous infusion was set to 2mL/h, a bolus dose of 3mL, and a lockout interval of 15 minutes

Drug: the drug of intravenous patient-controlled analgesia

Interventions

the drug of intravenous patient-controlled analgesia DRUG

At 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.

Also known as: intravenous patient-controlled analgesia (IV-PCA)

Butorphanol group(group B); Fentanyl group(group F); Oxycodone group(group O)

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who were scheduled for laparoscopic hysterectomy from W\&C BRANCH HOSPITAL OF JIANGSU PROVINCE HOSPITAL
• American Society of Anesthesiologists (ASA) physical status classification 1 to 2,
• Women aged 40-65
• Weight 50-80 kg

You may not qualify if:

• History of opioids abuse and allergy and contraindication to opioid drugs
• bronchial asthma; coronary heart disease; severe hypertension; diabetes mellitus;
• hepatic, and renal dysfunction (glutamyl aminotransferase\> 40U or aspartate aminotransferase\> 35U; urea nitrogen\> 8.2 μmol / L, creatinine\> 133 μmol / L),
• History of brain damage or psychiatric disease
• Patients with coagulopathy (PT\> 17 seconds or activated partial thromboplastin time (APTT)\> 47 seconds);
• pregnant or lactating women;
• Those with long-term constipation;
• History of digestive diseases;
• history of gastrointestinal disease (peptic ulcer disease, Crohn's disease, or ulcerative colitis)
• Participants in other drug trials in the past three months. （11）After randomization and allocation, patients were withdrawn if laparoscopy was converted to open surgery or if they required reinvestigation for postoperative bleeding.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead

Study Sites (1)

The First Affiliated Hospital with Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Related Publications (1)

• Guo M, Liu S, Gao J, Han C, Yang C, Liu C. The effects of fentanyl, oxycodone, and butorphanol on gastrointestinal function in patients undergoing laparoscopic hysterectomy: a prospective, double-blind, randomized controlled trial. BMC Anesthesiol. 2022 Feb 24;22(1):53. doi: 10.1186/s12871-022-01594-9.

  PMID: 35209847 DERIVED

MeSH Terms

Conditions

Uterine Cervical Neoplasms; Endometrial Neoplasms; Adenomyosis; Leiomyoma

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Neoplasms, Muscle Tissue; Neoplasms, Connective and Soft Tissue; Neoplasms by Histologic Type

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Cunming Liu, doctorate

  The First Affiliated Hospital with Nanjing Medical University

  PRINCIPAL INVESTIGATOR

• Shijiang Liu, Master

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

• Chuanbao Han

  The First Affiliated Hospital with Nanjing Medical University

  STUDY DIRECTOR

• Minna Guo

  The First Affiliated Hospital with Nanjing Medical University

  STUDY CHAIR

Central Study Contacts

Cunming Liu, doctorate

CONTACT

13951890866; 1335587409@qq.com

Minna Guo, Master

CONTACT

18835162576; 1653474602@qq.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 5, 2020
• First Posted: March 4, 2020
• Study Start: March 2, 2020
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: April 24, 2020

Record last verified: 2020-04

Locations

CN (1)