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Completed

NCT Number: NCT04396587

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

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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Key information

Conditions

Opioid Use

Age range

18 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

  1. Respiratory rate

    Time frame: 20 minutes after administration

    Number of breaths per minute

  2. 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

  3. 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

  1. itch

    Time frame: 20 minutes after administration

    itch

  2. nausea or vomiting

    Time frame: 20 minutes after administration

    nausea or vomiting

  3. drowsiness

    Time frame: 20 minutes after administration

    drowsiness

  4. sweating

    Time frame: 20 minutes after administration

    sweating

Sponsors and collaborators

Lead sponsor

Peking University People's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
May 20, 2020
Registry last updated
May 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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