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Combination of Nalbuphine and Dexmedetomidine Versus Sufentanil and Dexmedetomidine on Patients

NCT05445024 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2023-04-04

No results posted yet for this study

Summary

Surgical pain refers to pain that occurs immediately after surgery, including physical pain and visceral pain. Thus, it severely challenges the proper use of analgesics for patients undergoing laparoscope gastrointestinal surgery to clinicians.

Nalbuphine is a mixed agonist-antagonist opioid. The investigators hypothesized that the clinical effect of nalbuphine in combination with dexmedetomidine might be different from that of sufentanil in combination with dexmedetomidine.

So, the investigators performed a nalbuphine and dexmedetomidine dose finding study, for the patient controlled anaesthesia (PCA) after the laparoscopic gastrointestinal surgery, to establish their 95% effective dose (ED95). The investigators then compared the clinical effect and adverse events of the newly established dosing regimen of nalbuphine combined with dexmedetomidine, to the equivalent dosing of sufentanil combined with dexmedetomidine, in the same patient population.

Conditions

  • Laparoscopic
  • Gastrointestinal Surgery

Interventions

PROCEDURE

nalbuphine group

nalbuphine ED95, dexmedetomidine ED95 and ondansetron 16mg were added into normal saline to a total of 100ml

PROCEDURE

sufentanil group

sufentanil (1/1000\* nalbuphine ED95), dexmedetomidine ED95 and ondansetron 16mg were added into normal saline to a total of 100ml

Sponsors & Collaborators

  • Qianfoshan Hospital

    lead OTHER

Principal Investigators

  • Meng Lv, doctor · Qianfoshan Hospital, The First Hospital affiliated of Shandong First Medical University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-01-01
Primary Completion
2023-11-30
Completion
2023-12-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05445024 on ClinicalTrials.gov