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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

4342 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-05-01

Study Completion Date

2022-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Realtime Detection for Individual Variation of Analgesic ：A Comparison of Sufentanil vs Fentanyl

NCT01748071

Surgery Individuality

COMPLETED

the Effect of Different Drugs and Infusion Ways on Degree of Postoperative Comfort

NCT04111328

Analgesia, Patient-Controlled

COMPLETED PHASE4

Effect of Butorphanol Combined With Flurbiprofen Axetil on Preventing Hyperalgesia Induced by Remifentanil in Patients

NCT02043366

Pain Anesthesia

COMPLETED NA

Oxycodone Versus Sufentanil in Patient-controlled Intravenous Analgesia After Laparoscopic Hysterectomy

NCT06690307

Laparoscopic Hysterectomy

RECRUITING PHASE4

Analgesia Effects of Nalbuphine vs Sulfentanil

NCT02604797

C.Delivery; Surgery (Previous), Gynecological

UNKNOWN NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Gastrointestinal Surgery

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SN group

sufentanil 100 μ g + nalbuphine 40 mg

Group Type EXPERIMENTAL

sufentanil + nalbuphine

Intervention Type DRUG

sufentanil 100 μ g + nalbuphine 40 mg

HN group

hydromorphone 10 mg+ nalbuphine 40 mg

Group Type EXPERIMENTAL

hydromorphone + nalbuphine

Intervention Type DRUG

hydromorphone 10 mg+ nalbuphine 40 mg

S group

sufentanil 200 μ g,

Group Type EXPERIMENTAL

Sufentanil

Intervention Type DRUG

sufentanil 200 μ g

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

sufentanil + nalbuphine

sufentanil 100 μ g + nalbuphine 40 mg

Intervention Type DRUG

Sufentanil

sufentanil 200 μ g

Intervention Type DRUG

hydromorphone + nalbuphine

hydromorphone 10 mg+ nalbuphine 40 mg

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes