Skip to main content
Clinical Trials/NCT05576675
NCT05576675
Completed
Phase 3

Patient-controlled Intravenous Analgesia Combined With Different Opioid Receptors for Gastrointestinal Surgery

Xijing Hospital1 site in 1 country4,342 target enrollmentMay 1, 2018

Overview

Phase
Phase 3
Intervention
sufentanil + nalbuphine
Conditions
Gastrointestinal Surgery
Sponsor
Xijing Hospital
Enrollment
4342
Locations
1
Primary Endpoint
the incidence of insufficient static and dynamic analgesia dynamic analgesia
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

Objective To evaluate the effect of patient-controlled intravenous analgesia combined with different opioid receptors for gastrointestinal surgery. Methods A total of 4342 patients who underwent gastrointestinal postoperative analgesia in the first affiliated Hospital of Air Force military Medical University from May 2018 to March 2022 were collected retrospectively. The patient-controlled intravenous analgesia regimen in this study was composed of different opioid receptor drugs:sufentanil combined with nalbuphine group (SN group) and Hydromorphone combined with nalbuphine group (HN group) and single opioid receptor group: sufentanil group (S group). SN group ,HN group and S group were treated with sufentanil 100 μ g + nalbuphine 40 mg, hydromorphone 10 mg+ nalbuphine 40 mg, sufentanil 200 μ g, diluted to 100 ml, background dose 1 ml/h, PCA dose 0.5 ml, locking time 10 min. The demographic data of the three groups were collected, the number of patients with insufficient static and dynamic analgesia (VAS ≥ 4) at 24 and 48 hours after operation, the adverse reactions at 24 and 48 hours after operation, the first exhaust time and the first ambulation time were collected, evaluate the analgesic effect of combination of different opioid receptor drugs and single opioid receptor drugs in PCIA after gastrointestinal surgery.

Detailed Description

Control group:S group Test group:SN group and HN group Observation index:the number of patients with insufficient static and dynamic analgesia (VAS ≥ 4) at 24 and 48 hours after operation, the adverse reactions(drowsiness, nausea and vomiting, respiratory depression, dizziness) at 24 and 48 hours after operation, the first exhaust time and the first ambulation time were collected

Registry
clinicaltrials.gov
Start Date
May 1, 2018
End Date
March 31, 2022
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Xijing Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 18-75 years ,there is no gender limit,ASA grade Ⅰ-Ⅱ

Exclusion Criteria

  • BMI \> 35 kg/m2, history of upper abdominal surgery, history of analgesic or hormone use before operation, history of depression or chronic pain before operation, infection before operation and ICU after operation

Arms & Interventions

SN group

sufentanil 100 μ g + nalbuphine 40 mg

Intervention: sufentanil + nalbuphine

HN group

hydromorphone 10 mg+ nalbuphine 40 mg

Intervention: hydromorphone + nalbuphine

S group

sufentanil 200 μ g,

Intervention: Sufentanil

Outcomes

Primary Outcomes

the incidence of insufficient static and dynamic analgesia dynamic analgesia

Time Frame: 48 hours after operation

VAS ≥ 4

Secondary Outcomes

  • the incidence of adverse reactions(48 hours after operation)

Study Sites (1)

Loading locations...

Similar Trials