Clincosm LogoSign in Get a demo

The 90% Effective Dose of Nalbuphine in Mechanical Ventilated Patients in the ICU

Sponsor
Hua-Qing Shu (Other)
Overall Status
Unknown status
CT.gov ID
NCT03786887
Collaborator
(none)
60
Enrollment
1
Location
1
Arm
11.2
Anticipated Duration (Months)
5.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this study is to determine the effective nalbuphine dose in 90% of intubated patients in the ICU, including the continuous infusion dose and a bolus dose during moving to the lateral decubitus position. Pain will assessed using a Behavioural Pain Scale (BPS) requiring a score of 3-4.

Condition or Disease Intervention/Treatment Phase
Phase 4

Detailed Description

The continuous nalbuphine infusion dose starts at 100ug/kg/h, if the BPS scores reaches 3-4, the continuous infusion dose would be decreased by 20 ug/kg/h for next patients. If not, increased by 20 ug/kg/h.

The nalbuphine bolus is injected 5 min before turning the patients and the dose (starting at 0) is increased by 0.05 mg/kg, prior to each subsequent turn to lateral decubitus until a BPS score of 3-4 is obtained.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Intervention Model:
Sequential Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The 90% Effective Dose of Nalbuphine in Mechanical Ventilated Patients in the ICU
Actual Study Start Date :
Oct 24, 2018
Anticipated Primary Completion Date :
Oct 1, 2019
Anticipated Study Completion Date :
Oct 1, 2019

Arms and Interventions

Arm Intervention/Treatment
Experimental: Nalbuphine

Drug: Nalbuphine
dosage of nalbuphine

Outcome Measures

Primary Outcome Measures

  1. Continuous pumping dose of nalbuphine [2 days]

    The effective continuous infusion dose of nalbuphine to obtain a satisfactory analgesia

  2. Nalbuphine bolus dose [3 days]

    The effective dose of a nalbuphine bolus to obtain a satisfactory analgesia

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  • Mechanical invasive ventilation

  • Sedated only with nalbuphine

Exclusion Criteria:

  • Pregnant or breast-feeding woman

  • Age below 18 or over 80 years

  • An indication for deep sedation (e.g.the initial stage of septic shock, acute brain injury or acute respiratory distress syndrome)

  • Renal dialysis

  • The inability to assess pain by the BPS scale (e.g. paralysis)

  • BMI less than 18 or more than 35

  • Preadmission use of opioid analgesic for chronic pain

  • Severe hepatic failure

  • State of consciousness with impossibility to use self-assessment scale; monoamine oxidase inhibitors

Contacts and Locations

Locations

Site City State Country Postal Code
1 Department of Critical Care Medicine, Union Hospital, Wuhan Wuhan China

Sponsors and Collaborators

  • Hua-Qing Shu

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hua-Qing Shu, Associate chief physician, Wuhan Union Hospital, China
ClinicalTrials.gov Identifier:
NCT03786887
Other Study ID Numbers:
  • HShu
First Posted:
Dec 26, 2018
Last Update Posted:
Dec 26, 2018
Last Verified:
Nov 1, 2018
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 Hua-Qing Shu, Associate chief physician, Wuhan Union Hospital, China
mechanical ventilation
nalbuphine
Additional relevant MeSH terms:
Nalbuphine

Study Results

No Results Posted as of Dec 26, 2018