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Comparison of the Analgesic Effect of Oliceridine Versus Morphine or Sufentanil for Postoperative Analgesia in Lumbar Surgeries: a Randomized Control Trial

A

Anqing Municipal Hospital

Status

Enrolling

Conditions

Morphine
Sufentanil
Oliceridine
Validity
Safety

Treatments

Drug: Sufentanil
Drug: Morphine
Drug: Oliceridine

Study type

Interventional

Funder types

Other

Identifiers

NCT06990893
Sun Ling

Details and patient eligibility

About

Objective: To compare the application of oxelidine in postoperative analgesia after orthopedic lumbar spine surgery with morphine or sufentanil, and to explore the efficacy and safety of postoperative analgesia.

Method: Researchers included 90 patients with American Society of Anesthesiologists (ASA) physical conditions I and III, aged 18 to 65 years, who were scheduled to undergo orthopedic lumbar general anesthesia surgery at an appropriate time. The patients were randomly divided into 3 groups, with 30 cases in each group: The oxeridine group (Group A), where a loading dose of 1.5mg of oxeridine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.01mg/kg-1.h-1 was connected. Oxeridine was mixed with normal saline to 100ml at a rate of 2ml/h. Morphine group (Group M), a loading dose of 4mg of morphine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03mg.kg-1.h-1 morphine was connected with normal saline to 100ml at a rate of 2ml/h. Sufentanil group (Group S), a 4u loading dose of sufentanil was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03ug.kg-1.h-1 was connected. Sufentanil was combined with normal saline to 100ml at a rate of 2ml/h.The resting and exercise VAS pain scores of the three groups of patients at 30 minutes, 2 hours, 6 hours, 12 hours, 24 hours and 48 hours after the operation and adverse reactions within 48 hours were recorded.

Enrollment

90 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Lumbar spine surgery with ASA grades I-III
  • Aged 18-65 years
  • Ethically, the patient voluntarily accepted this trial and signed the informed consent form

Exclusion criteria

  • Severe respiratory and circulatory system diseases
  • Nervous system disease
  • Mental and psychological disorders
  • Abnormal liver and kidney functions
  • Participated in another drug clinical research within the past 30 days

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

90 participants in 3 patient groups

The oliceridine group(A)
Experimental group
Description:
A loading dose of 1.5mg of oliceridine was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.01 mg.kg-1.h-1 orselidine was connected and diluted with normal saline to 100ml at a rate of 2ml per hour
Treatment:
Drug: Oliceridine
The morphine group(M)
Experimental group
Description:
A loading dose of 4mg of morphine was intravenously injected. Ten minutes later, an intravenous analgesic pump was connected to 0.03mg.kg-1.h-1 morphine mixed with normal saline to 100ml at a rate of 2ml per hour
Treatment:
Drug: Morphine
The sufentanil group(S)
Experimental group
Description:
A loading dose of 4ug of sufentanil was intravenously injected. Ten minutes later, an intravenous analgesic pump of 0.03ug.kg-1.h-1 was connected. Sufentanil was mixed with normal saline to 100ml at a rate of 2ml per hour
Treatment:
Drug: Sufentanil

Trial contacts and locations

1

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Central trial contact

Sun Ling Lu Sun Ling LU, Master's degree

Data sourced from clinicaltrials.gov

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