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

Study Overview
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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 3 groups, with 20 patients in each group. Sufentanil(0.1μg/kg), Hydromorphone(20μg/kg), or Oxycodone(60μg/kg) 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.

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

Conditions
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Opioid Use

Intervention / Treatment
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* Drug: Sufentanil
* Drug: Hydromorphone
* Drug: Oxycodone
* Drug: normal Saline


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sufentanil<br>Sufentanil(0.1μg/kg) | Drug: Sufentanil<br>* Sufentanil(0.1μg/kg) was administered before anesthesia induction.<br>|
| Experimental: Hydromorphone<br>Hydromorphone(20μg/kg） | Drug: Hydromorphone<br>* Hydromorphone(20μg/kg)was administered before anesthesia induction.<br>|
| Experimental: Oxycodone<br>Oxycodone(60μg/kg) | Drug: Oxycodone<br>* Oxycodone(60μg/kg) was administered before anesthesia induction.<br>|
| Placebo Comparator: normal saline<br>10ml | Drug: normal Saline<br>* normal saline 10ml<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| itch | itch | 20 minutes after administration | 
| nausea or vomiting | nausea or vomiting | 20 minutes after administration | 
| drowsiness | drowsiness | 20 minutes after administration | 
| sweating | sweating | 20 minutes after administration |