Non-analgesic Effects Produced by Equipotent Analgesic Doses of Sufentanil, Hydromorphone, and Oxycodone

Phase 4

Completed

• Conditions: Opioid Use
• Interventions: Drug: Oxycodone; Drug: normal Saline; Drug: Sufentanil; Drug: Hydromorphone

• Registration Number: NCT04396587
• Lead Sponsor: Peking University People's Hospital

Brief Summary

This study aimed to investigate Non-analgesic Effects Produced by Equipotent Analgesic Doses of Sufentanil, Hydromorphone, and Oxycodone in female patients. Methods: A total of 60 patients were randomly divided into 4 groups, with 20 patients in each group. Sufentanil(0.1μg/kg), Hydromorphone(20μg/kg), or Oxycodone(60μg/kg) ,saline(10ml)was administered before anesthesia induction. Bispectral Index (BIS), Respiratory rate(RR), other non-analgesic effects at Tb (entering room), T0 (drug administration), T1 (2min), T2 (4min), T3(6min), T4(8min), T5(10min), T6(20min) were recorded.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-16
• Study First Submitted QC: 2020-05-19
• Study Start: 2020-05-20
• Study First Posted: 2020-05-20
• Primary Completion: 2023-01-01
• Study Completion: 2023-06-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 80

Inclusion Criteria

• American Society of Anesthesiologists GradeⅠ-II;
• Patients undergo low-risk elective surgery for benign diseases (including laparoscopic ovarian cyst removal, laparoscopic tubal ligation, laparoscopic tubal drainage, breast operation, thyroid operation, etc) ;
• Aged 18-45 years;
• Body Mass Index 18-25kg/m2, weight 40-65 kilograms;
• Agreed to participate in the research

Exclusion Criteria

• Difficult airway;
• upper respiratory tract infection within 2 weeks;
• history of allergy or long-term use of propofol and opioids;
• self-rating anxiety scale before operation indicates anxiety;
• pregnancy or lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oxycodone	Oxycodone	Oxycodone(60μg/kg)
normal saline	normal Saline	10ml
Sufentanil	Sufentanil	Sufentanil(0.1μg/kg)
Hydromorphone	Hydromorphone	Hydromorphone(20μg/kg）

Primary Outcome Measures

Name	Time	Method
Respiratory rate	20 minutes after administration	Number of breaths per minute
Bispectral Index	20 minutes after administration	bispectral index(BIS): assessing the sedation, placed on the patient's forehead, BIS values 0-100, and the higher score means patients are more conscious
dizziness	20 minutes after administration	a temporary feeling that your sense of balance is not good and that you may fall down

Secondary Outcome Measures

Name	Time	Method
itch	20 minutes after administration	itch
nausea or vomiting	20 minutes after administration	nausea or vomiting
drowsiness	20 minutes after administration	drowsiness
sweating	20 minutes after administration	sweating

Trial Locations

Locations (1)

Peking University People's Hospital; 🇨🇳 Beijing, Beijing, China