NCT04396587

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started May 2020

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 16, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 20, 2020

Completed
Same day until next milestone

Study Start

First participant enrolled

May 20, 2020

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2023

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

May 30, 2024

Status Verified

May 1, 2024

Enrollment Period

2.6 years

First QC Date

May 16, 2020

Last Update Submit

May 28, 2024

Conditions

Opioid Use

Outcome Measures

Primary Outcomes (3)

  • Respiratory rate

    Number of breaths per minute

    20 minutes after administration

  • 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

Secondary Outcomes (4)

  • itch

    20 minutes after administration

  • nausea or vomiting

    20 minutes after administration

  • drowsiness

    20 minutes after administration

  • sweating

    20 minutes after administration

Study Arms (4)

Sufentanil

EXPERIMENTAL

Sufentanil(0.1μg/kg)

Drug: Sufentanil

Hydromorphone

EXPERIMENTAL

Hydromorphone(20μg/kg）

Drug: Hydromorphone

Oxycodone

EXPERIMENTAL

Oxycodone(60μg/kg)

Drug: Oxycodone

normal saline

PLACEBO COMPARATOR

10ml

Drug: normal Saline

Interventions

SufentanilDRUG

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

Sufentanil
HydromorphoneDRUG

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

Hydromorphone
OxycodoneDRUG

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

Oxycodone
normal SalineDRUG

normal saline 10ml

normal saline

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Interventions

SufentanilHydromorphoneOxycodoneSaline Solution

Intervention Hierarchy (Ancestors)

FentanylPiperidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsMorphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsCodeineCrystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical Preparations

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 16, 2020

First Posted

May 20, 2020

Study Start

May 20, 2020

Primary Completion

January 1, 2023

Study Completion

June 1, 2023

Last Updated

May 30, 2024

Record last verified: 2024-05

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)