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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-20

Study Completion Date

2023-06-01

Brief Summary

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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.

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Detailed Description

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Conditions

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Opioid Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators

Study Groups

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Sufentanil

Sufentanil(0.1μg/kg)

Group Type EXPERIMENTAL

Sufentanil

Intervention Type DRUG

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

Hydromorphone

Hydromorphone(20μg/kg）

Group Type EXPERIMENTAL

Hydromorphone

Intervention Type DRUG

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

Oxycodone

Oxycodone(60μg/kg)

Group Type EXPERIMENTAL

Oxycodone

Intervention Type DRUG

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

normal saline

10ml

Group Type PLACEBO_COMPARATOR

normal Saline

Intervention Type DRUG

normal saline 10ml

Interventions

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Sufentanil

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

Intervention Type DRUG

Hydromorphone

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

Intervention Type DRUG

Oxycodone

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

Intervention Type DRUG

normal Saline

normal saline 10ml

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No