---
title: Non-analgesic Effects Produced by Equipotent Analgesic Doses of Sufentanil, Hydromorphone, and Oxycodone
nct_id: NCT04396587
overall_status: COMPLETED
phase: PHASE4
sponsor: "Peking University People's Hospital"
study_type: INTERVENTIONAL
primary_condition: Opioid Use
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT04396587.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT04396587"
ct_last_update_post_date: 2024-05-30
last_seen_at: "2026-05-12T06:38:40.785Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Non-analgesic Effects Produced by Equipotent Analgesic Doses of Sufentanil, Hydromorphone, and Oxycodone

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

**NCT ID:** [NCT04396587](https://clinicaltrials.gov/study/NCT04396587)

## Key Facts

- **Status:** COMPLETED
- **Phase:** PHASE4
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 80
- **Lead Sponsor:** Peking University People's Hospital
- **Conditions:** Opioid Use
- **Start Date:** 2020-05-20
- **Completion Date:** 2023-06-01
- **CT.gov Last Update:** 2024-05-30

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 50 Years
- **Sex:** FEMALE
- **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.
```

## Arms

- **Sufentanil** (EXPERIMENTAL) — Sufentanil(0.1μg/kg)
- **Hydromorphone** (EXPERIMENTAL) — Hydromorphone(20μg/kg）
- **Oxycodone** (EXPERIMENTAL) — Oxycodone(60μg/kg)
- **normal saline** (PLACEBO_COMPARATOR) — 10ml

## Interventions

- **Sufentanil** (DRUG) — Sufentanil(0.1μg/kg) was administered before anesthesia induction.
- **Hydromorphone** (DRUG) — Hydromorphone(20μg/kg)was administered before anesthesia induction.
- **Oxycodone** (DRUG) — Oxycodone(60μg/kg) was administered before anesthesia induction.
- **normal Saline** (DRUG) — normal saline 10ml

## Primary Outcomes

- **Respiratory rate** _(time frame: 20 minutes after administration)_ — Number of breaths per minute
- **Bispectral Index** _(time frame: 20 minutes after administration)_ — 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
- **dizziness** _(time frame: 20 minutes after administration)_ — a temporary feeling that your sense of balance is not good and that you may fall down

## Secondary Outcomes

- **itch** _(time frame: 20 minutes after administration)_
- **nausea or vomiting** _(time frame: 20 minutes after administration)_
- **drowsiness** _(time frame: 20 minutes after administration)_
- **sweating** _(time frame: 20 minutes after administration)_

## Locations (1)

- Peking University People's Hospital, Beijing, Beijing Municipality, China

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.peking university people's hospital|beijing|beijing municipality|china` — added _(2026-05-12)_

---

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