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

Non-analgesic Effects Produced by Equipotent Analgesic Doses of Sufentanil, Hydromorphone, and Oxycodone in Female Patients Before Anesthesia Induction

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 3 groups, with 20 patients in each group. Sufentanil(0.1μg/kg), Hydromorphone(20μg/kg), or Oxycodone(60μg/kg) 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.

Study Overview

• Status: Completed
• Conditions: Opioid Use
• Intervention / Treatment: Drug: Sufentanil; Drug: Hydromorphone; Drug: Oxycodone; Drug: normal Saline

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Qi Yan, MD; Phone Number: 13811319638; Email: yanqi04@163.com
• Study Contact Backup: Name: Yi Feng, MD; Phone Number: 01088325581; Email: yifeng65@163.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100044
      • Peking University People's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Sufentanil; Sufentanil(0.1μg/kg)	Drug: Sufentanil; Sufentanil(0.1μg/kg) was administered before anesthesia induction.
Experimental: Hydromorphone; Hydromorphone(20μg/kg）	Drug: Hydromorphone; Hydromorphone(20μg/kg)was administered before anesthesia induction.
Experimental: Oxycodone; Oxycodone(60μg/kg)	Drug: Oxycodone; Oxycodone(60μg/kg) was administered before anesthesia induction.
Placebo Comparator: normal saline; 10ml	Drug: normal Saline; normal saline 10ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Bispectral Index	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	20 minutes after administration
dizziness	a temporary feeling that your sense of balance is not good and that you may fall down	20 minutes after administration
Respiratory rate	Number of breaths per minute	20 minutes after administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
itch	itch	20 minutes after administration
nausea or vomiting	nausea or vomiting	20 minutes after administration
drowsiness	drowsiness	20 minutes after administration
sweating	sweating	20 minutes after administration

Collaborators and Investigators

• Sponsor: Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2020
• Primary Completion (Actual): January 1, 2023
• Study Completion (Actual): June 1, 2023

Study Registration Dates

• First Submitted: May 16, 2020
• First Submitted That Met QC Criteria: May 19, 2020
• First Posted (Actual): May 20, 2020

Study Record Updates

• Last Update Posted (Estimated): November 22, 2023
• Last Update Submitted That Met QC Criteria: November 20, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Oxycodone; Sufentanil; Hydromorphone
• Other Study ID Numbers: NAESHO

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No