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

• Sponsor: Xijing Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05576675
• Collaborator: (none)
• Enrollment: 4,342
• Location: 1
• Arms: 3
• Actual Duration (Months): 47
• Patients Per Site Per Month: 92.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Gastrointestinal Surgery	Drug: sufentanil + nalbuphine; Drug: Sufentanil; Drug: hydromorphone + nalbuphine	Phase 3

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 4342 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Patient-controlled Intravenous Analgesia Combined With Different Opioid Receptors for Gastrointestinal Surgery
• Actual Study Start Date: May 1, 2018
• Actual Primary Completion Date: Mar 31, 2022
• Actual Study Completion Date: Mar 31, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: SN group sufentanil 100 μ g + nalbuphine 40 mg	Drug: sufentanil + nalbuphine; sufentanil 100 μ g + nalbuphine 40 mg
Experimental: HN group hydromorphone 10 mg+ nalbuphine 40 mg	Drug: hydromorphone + nalbuphine; hydromorphone 10 mg+ nalbuphine 40 mg
Experimental: S group sufentanil 200 μ g,	Drug: Sufentanil; sufentanil 200 μ g

Outcome Measures

Primary Outcome Measures

1. the incidence of insufficient static and dynamic analgesia dynamic analgesia [24 hours after operation]

   VAS ≥ 4

2. the incidence of insufficient static and dynamic analgesia dynamic analgesia [48 hours after operation]

   VAS ≥ 4

Secondary Outcome Measures

1. the incidence of adverse reactions [24 hours after operation]

   dizziness, nausea and vomiting

2. the incidence of adverse reactions [48 hours after operation]

   dizziness, nausea and vomiting

Other Outcome Measures

1. first exhaust time [immediately after operation]

   first exhaust time

2. first ambulation time [immediately after operation]

   first ambulation time

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	YANLI	XIan	Shanxi	China	710032

Sponsors and Collaborators

• Xijing Hospital

Investigators

• Study Chair: Yan LI, The First Affiliated Hospital of the Air Force Medical Universtiy
• Study Chair: jing LIN, The First Affiliated Hospital of the Air Force Medical Universtiy

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Xijing Hospital
• ClinicalTrials.gov Identifier: NCT05576675
• Other Study ID Numbers: xijingHospital
• First Posted: Oct 12, 2022
• Last Update Posted: Oct 12, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Xijing Hospital: patient-controlled intravenous analgesia; gastrointestinal surgery
• Additional relevant MeSH terms: Sufentanil; Dsuvia; Hydromorphone; Nalbuphine

Study Results

No Results Posted as of Oct 12, 2022