Comparing Post-Operative Analgesic Effects of PCAM With Dexmedetomidine 1 mcg/ml vs PCAM With Dexmedetomidine 2 mcg/ml

NCT05288738 | Completed Phase 4

• 1 other identifier: FF-2019-543
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

PCA morphine have been a common method in providing excellent analgesia for post-operative period. However, the usage of morphine is not without any side effects such as nausea, vomiting, respiratory depression, and over sedation. Many adjunct have been used in combination with morphine to observe the opioid sparing effects at the same time providing good analgesia. Dexmedetomidine is a potent and selective alpha-2 receptor agonist with sedative, anxiolytic, sympatholytic, and analgesic effects. As dexmedetomidine and morphine act via different mechanism, this combination produces synergistic analgesic effects. The objective of our study was to observe the effectiveness in pain relief between two low concentration of dexmedetomidine (2 mcg/ml versus 1 mcg/ml) as an adjunct to PCA morphine 1 mg/ml.

Conditions

Post-Operative Analgesia; Opioid Use, Unspecified; Laparotomy Surgery

Keywords

PCA Morphine; Dexmedetomidine; Morphine-dexmedetomidine; PCA-adjunct

Outcome Measures

Primary Outcomes (1)

• Total morphine consumption

  Measure the total PCA morphine (mg) consumption post laparotomy

  24 hours

Secondary Outcomes (3)

• Morphine side effects

  at 6, 12, and 24 hours post laparotomy

• Analgesic effects

  at 6, 12, and 24 hours post laparotomy

• Dexmedetomidine side effects

  at 6, 12, and 24 hours post laparotomy

Study Arms (2)

Group D1

ACTIVE COMPARATOR

PCA morphine 1mg/ml

Drug: Dexmedetomidine 1 mcg/ml

Group D2

ACTIVE COMPARATOR

PCA morphine 1mg/ml

Drug: Dexmedetomidine 2 mcg/ml

Interventions

Dexmedetomidine 1 mcg/ml DRUG

34 patients received PCA morphine 1 mg/ml with combination of dexmedetomidine 1 mcg/ml

Also known as: Precedex

Group D1

Dexmedetomidine 2 mcg/ml DRUG

34 patients received PCA morphine 1 mg/ml with combination of dexmedetomidine 2 mcg/ml

Also known as: Precedex

Group D2

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• ASA 1 \& 2 patient
• going for elective or emergency laparotomy surgery

You may not qualify if:

• patient with known allergy to morphine or dexmedetomidine
• Creatinine clearance less then 30ml/min
• Current alcohol dependency
• Psychiatric illness on regular sedative-hypnotic drugs
• significant obstructive sleep apnoea (OSA)
• Chronic pain patient who on regular opioids

Sponsors & Collaborators

• Universiti Kebangsaan Malaysia Medical Centre: lead

Study Sites (1)

Universiti Kebangsaan Malaysia Medical Center

Cheras, Kuala Lumpur, 56000, Malaysia

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Yeoh Chih Nie, MMed

  Universiti Kebangsaan Malaysia Medical Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 10, 2022
• First Posted: March 21, 2022
• Study Start: December 9, 2019
• Primary Completion: December 8, 2020
• Study Completion: January 10, 2021
• Last Updated: March 21, 2022

Record last verified: 2021-04

Locations

MY (1)