Recovery of stomach function after treatment with strong analgesics.

Recovery of gastric function after treatment with shortacting opioids. - Opioids and EGG

Status

Active, not recruiting

Phases

Phase 1Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-005489-46-SE

Enrollment

Registered

2015-12-15

Start date

2016-02-02

Completion date

Unknown

Last updated

2024-07-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The effect of opioids on gastric electrical activity MedDRA version: 18.1 Level: LLT Classification code 10018043 Term: Gastroparesis System Organ Class: 100000004856 MedDRA version: 18.1 Level: PT Classification code 10018044 Term: Gastroparesis postoperative System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 18.1 Level: LLT Classification code 10021227 Term: Idiopathic gastroparesis System Organ Class: 100000004856

Interventions

Pharmaceutical Form: Powder for solution for infusion INN or Proposed INN: REMIFENTANIL CAS Number: 132875-61-7 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentratio

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: ASA-class 1-2 non-smoker Women and Men Aged 18 - 65 y Body Mass Index (BMI) 18-30 Research person are able to undergo the study Signed and dated informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 70 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Pregnant or breastfeeding women Patophysiologi that affect gastric motility Medication that affect gastric motility History of abuse Other factor that the investigator consider important Already participated in the study

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of the trial is to explore gastric recovery after treatment with short-actings opioids.;Secondary Objective: Secondary objectives are to study the effects of opioids on gastric myoelectric activity and evaluation of safety variables.;Primary end point(s): Time to recovery (minutes) of normal gastric electrical activity defined as dominant frequency +/-10% of dominant frequency before opioid administration.;Timepoint(s) of evaluation of this end point: During the investigation	—

Measure

Time frame

Main Objective: The primary objective of the trial is to explore gastric recovery after treatment with short-actings opioids.;Secondary Objective: Secondary objectives are to study the effects of opioids on gastric myoelectric activity and evaluation of safety variables.;Primary end point(s): Time to recovery (minutes) of normal gastric electrical activity defined as dominant frequency +/-10% of dominant frequency before opioid administration.;Timepoint(s) of evaluation of this end point: During the investigation

—

Secondary

Measure	Time frame
Secondary end point(s): Changes in dominant frequency of after opioid administration Safety variables -Pulse, blodpressure, ECG changes - Oxygen saturation, respiratory rate - Consciousness ;Timepoint(s) of evaluation of this end point: During the investigation	—

Countries

Sweden

Contacts

Public ContactJakob Wallden

Umeå University

jakob.wallden@umu.se

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026