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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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04396587
Enrollment
80
Registered
2020-05-20
Start date
2020-05-20
Completion date
2023-06-01
Last updated
2024-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Opioid Use

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.

Interventions

DRUGSufentanil

Sufentanil(0.1μg/kg) was administered before anesthesia induction.

DRUGHydromorphone

Hydromorphone(20μg/kg)was administered before anesthesia induction.

DRUGOxycodone

Oxycodone(60μg/kg) was administered before anesthesia induction.

DRUGnormal Saline

normal saline 10ml

Sponsors

Peking University People's Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Respiratory rate20 minutes after administrationNumber of breaths per minute
Bispectral Index20 minutes after administrationbispectral index(BIS): assessing the sedation, placed on the patient's forehead, BIS values 0-100, and the higher score means patients are more conscious
dizziness20 minutes after administrationa temporary feeling that your sense of balance is not good and that you may fall down

Secondary

MeasureTime frameDescription
itch20 minutes after administrationitch
sweating20 minutes after administrationsweating
nausea or vomiting20 minutes after administrationnausea or vomiting
drowsiness20 minutes after administrationdrowsiness

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026