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

Peking University

Status and phase: Completed; Phase 4

Conditions: Opioid Use

Treatments: Drug: Sufentanil; Drug: normal Saline; Drug: Hydromorphone; Drug: Oxycodone

Study type: Interventional

Funder types: Other

Identifiers

NCT04396587

NAESHO

Details and patient eligibility

About

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.

Enrollment: 80 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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80 participants in 4 patient groups, including a placebo group

Sufentanil

Experimental group

Description:

Sufentanil(0.1μg/kg)

Treatment:

Drug: Sufentanil

Hydromorphone

Experimental group

Description:

Hydromorphone(20μg/kg）

Treatment:

Drug: Hydromorphone

Oxycodone

Experimental group

Description:

Oxycodone(60μg/kg)

Treatment:

Drug: Oxycodone

normal saline

Placebo Comparator group

Description:

10ml

Treatment:

Drug: normal Saline