The Effect of Analgesic Drugs on Respiratory Center

NCT ID: NCT04372342

Last Updated: 2020-05-04

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

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-01

Study Completion Date

2021-12-30

Brief Summary

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Opioids are commonly used in analgesic treatment of severe patients. Opioid receptors are divided into five types:,,, and.1 receptor is associated with analgesia and sedation above the spinal cord, while 2 receptor is associated with respiratory depression, bradycardia, euphoric sensation, pruritus, pupil contraction, inhibition of intestinal motility and other side effects.Κ receptors play a role of spinal analgesia, sedation and diuresis.Δ receptors associated with spinal analgesia and respiratory inhibition and regulate the activity of mu receptor.

Different opioid analgesics have different binding degree with different receptors, which determines the difference of analgesic effect and side effect, especially respiratory central inhibitory effect.Remifentanil is a pure opioid receptor agonist, mainly ACTS on the first and second receptors, binding to the second receptor is weak, in the analgesic, sedative effect, with opioid respiratory depression and hypotensive side effects, respiratory depression is dose dependent.Nalbuphine hydrochloride has strong analgesic effect, quick effect and long time by stimulating receptor, and has partial antagonistic effect on the receptor, so the incidence of respiratory depression is low in theory.The metabolic pathways of different opioids are also different. In particular, severe patients often need continuous opioid infusion for analgesia, which may lead to the accumulation of drugs and further affect the respiratory center.In the process of continuous application of different types of opioids to the analgesia of severe patients, the presence of respiratory center inhibition, the degree of inhibition and the dose-effect relationship have not been quantitatively evaluated.

Detailed Description

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Conditions

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The Effect of Analgesic Drugs on Respiratory Center

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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nalbuphine

Group Type EXPERIMENTAL

nalbuphine

Intervention Type DRUG

Nalbuphine hydrochloride has strong analgesic effect, quick effect and long time by stimulating receptor, and has partial antagonistic effect on the receptor, so the incidence of respiratory depression is low in theory.

remifentanil

Group Type PLACEBO_COMPARATOR

remifentanil

Intervention Type DRUG

remifentanil

Interventions

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nalbuphine

Nalbuphine hydrochloride has strong analgesic effect, quick effect and long time by stimulating receptor, and has partial antagonistic effect on the receptor, so the incidence of respiratory depression is low in theory.

Intervention Type DRUG

remifentanil

remifentanil

Intervention Type DRUG

Other Intervention Names

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remifentanil

Eligibility Criteria

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Inclusion Criteria

Patients with tracheal intubation transferred to ICU after surgery;Stop the use of sedative drugs continue to pump more than 2h into the vein, anesthesia awake can cooperate with the command action;Can withstand PSV ventilation; need pain relief treatment

Exclusion Criteria

Patients who cannot place transnasal gastric tube (EAdi catheter) beside the bed due to various reasons (such as massive gastrointestinal bleeding, esophagus and stomach surgery within the past 1 month, severe coagulation dysfunction);Patients with neuromuscular diseases: diseases that directly or indirectly inhibit respiratory centers and affect respiratory muscles;The patient is expected to die within 24 hours;Pregnant women, patients with malignant tumors;Patients with craniocerebral injury or ARDS who require deep sedation;Patients with agitated delirium.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Southeast University, China

OTHER

Sponsor Role collaborator

Chun Pan

OTHER

Sponsor Role lead

Responsible Party

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Chun Pan

Director

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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Zhongda Hospital, Southeast University

Nanjing, Jiangsu, China

Site Status RECRUITING

Countries

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China

Facility Contacts

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Ling Liu, Dr

Role: primary

+8613851435472

Other Identifiers

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nalbuphine

Identifier Type: -

Identifier Source: org_study_id

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