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

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04396587
• Other study ID #: NAESHO
• Status: Completed
• Phase: Phase 4
• Start date: May 20, 2020
• Est. completion date: June 1, 2023

Study information

• Verified date: May 2024
• Source: Peking University People's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 1, 2023
• Est. primary completion date: January 1, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• American Society of Anesthesiologists Grade?-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.

Related Conditions & MeSH terms

• Opioid Use

Intervention

Drug:
• Sufentanil
Sufentanil(0.1µg/kg) was administered before anesthesia induction.
• Hydromorphone
Hydromorphone(20µg/kg)was administered before anesthesia induction.
• Oxycodone
Oxycodone(60µg/kg) was administered before anesthesia induction.
• normal Saline
normal saline 10ml

Locations

Country	Name	City	State
China	Peking University People's Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Peking University People's Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Respiratory rate	Number of breaths per minute	20 minutes after administration
Primary	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
Primary	dizziness	a temporary feeling that your sense of balance is not good and that you may fall down	20 minutes after administration
Secondary	itch	itch	20 minutes after administration
Secondary	nausea or vomiting	nausea or vomiting	20 minutes after administration
Secondary	drowsiness	drowsiness	20 minutes after administration
Secondary	sweating	sweating	20 minutes after administration