Post-Operative AnalgesiaPhase 4NCT05288738
Comparing Post-Operative Analgesic Effects of PCAM With Dexmedetomidine 1 mcg/ml vs PCAM With Dexmedetomidine 2 mcg/ml
A Phase 4 study testing Dexmedetomidine 1 mcg/ml and Dexmedetomidine 2 mcg/ml in people with Post-Operative Analgesia and Opioid Use, Unspecified, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Post-Operative Analgesia, Opioid Use, Unspecified, Laparotomy Surgery
- What is being tested?
- Dexmedetomidine 1 mcg/ml and Dexmedetomidine 2 mcg/ml
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteMalaysia
- Study dates
- 9 Dec 2019to 10 Jan 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- ASA 1 \& 2 patient
- going for elective or emergency laparotomy surgery
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Malaysia1 site
Universiti Kebangsaan Malaysia Medical Center
Cheras, Kuala Lumpur, 56000
About this study
Official title: Comparing Post-Operative Analgesic Effects of Patient-Controlled Analgesia Morphine (PCAM) in Combination With Dexmedetomidine 1 mcg/ml Versus PCAM With Dexmedetomidine 2 mcg/ml
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.
Read more
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.
Read the detailed description
This was a double-blinded prospective randomised study conducted in Universiti Kebangsaan Malaysia Medical Centre from January 2020 till November 2020. This study was approved by Dissertation Committee of the Department of Anaesthesiology and Intensive Care, Universiti Kebangsaan Malaysia Medical Centre (UKMMC) and Medical Research and Ethics Committee of UKMMC.
Consent was taken during preoperative visit whereby patients were counselled on the use of PCA machine and assessment of pain score using visual analogue scale (VAS). All patients were not given sedative premedication before surgery. Induction of general anaesthesia was with IV fentanyl 2 mcg/kg, IV propofol 2 mg/kg and paralysed with IV rocuronium 0.6 mg/kg. Patients were given IV dexamethasone 0.2 mg/kg for postoperative nausea and vomiting (PONV) prophylaxis. Anaesthesia was maintained with sevoflurane to achieve MAC of 1.0 with oxygen and air in 1:1 ratio. All patients received IV morphine 0.1mg/kg intraoperatively, and surgical site infiltrated with levobupivacaine 0.5% 2 mg/kg. IV granisetron 1 mg was given to all patients at the end of the surgery and reversal was with IV neostigmine 0.05 mg/kg and IV atropine 0.02 mg/kg.
All patients were connected to the PCA morphine with test drugs after arrival in the recovery area. Patients were encouraged to self-administer the PCA whenever required. In an event of uncontrolled pain, rescue analgesia was with IV fentanyl 20 mcg boluses. All patients upon discharged to ward from recovery bay must have pain score (VAS) of less than 4, respiratory rate more than 10, MAP > 65 mmHg and HR > 60 beats/minute.
Patients were followed up at 6, 12, and 24 hours after surgery to look at the cumulative PCA morphine usage, incidence of nausea and vomiting, sedation score, respiratory depression (respiratory rate < 10 breath/min/). Side effects from dexmedetomidine namely hypotension (MAP < 65) and bradycardia (HR < 60) were also documented. The severity of nausea and vomiting was defined as mild, moderate, or severe while sedation was assessed according to five levels: 0, 1, 2, 3 and 4.
The power calculation for this study was based on a pilot study observing PCA consumption in the first 24 hours after surgery, with a mean difference, 14.67 and pooled standard deviation 20.27 in regard to dosage delivered comparing PCA morphine with dexmedetomidine 1 mcg/ml to PCA morphine with dexmedetomidine 2 mcg/ml. A group of 34 subjects each would be needed for a study with an alpha level of 0.05 (two-tailed) and a beta level of 0.2 (80% power) including 10% dropout rate.
Data were analysed using IBMR SPSSRs Statistics MacOS version 26.0 (IBM Corporation, New York, United States of America). The results were presented as frequency (percentage) and standard deviation whenever appropriate. The cumulative PCA morphine and dexmedetomidine usage pain score was analysed using the Mann-Whitney U-test. The incidence of sedation and PONV was analysed using Chi-square. Heart rate and blood pressure were analysed using independent T-test. A probability level of < 0.05 was considered to be statistically significant.
- Being tested
- Dexmedetomidine 1 mcg/ml, Dexmedetomidine 2 mcg/ml
- Keywords
- PCA Morphine, Dexmedetomidine, Morphine-dexmedetomidine, PCA-adjunct
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine 1 mcg/mlDrug
Also called Precedex
34 patients received PCA morphine 1 mg/ml with combination of dexmedetomidine 1 mcg/ml
Dexmedetomidine 2 mcg/mlDrug
Also called Precedex
34 patients received PCA morphine 1 mg/ml with combination of dexmedetomidine 2 mcg/ml
| Study group | Role | What they receive |
|---|---|---|
| Group D1 | Active comparator | PCA morphine 1mg/ml Receives: Drug: Dexmedetomidine 1 mcg/ml |
| Group D2 | Active comparator | PCA morphine 1mg/ml Receives: Drug: Dexmedetomidine 2 mcg/ml |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total morphine consumption
Measure the total PCA morphine (mg) consumption post laparotomy
Measured: 24 hours
Secondary outcomes (3)
Morphine side effects
Assess the frequency and severity of morphine side effects with the use of PCA morphine post laparotomy (PONV, over sedation, respiratory depression)
Measured: at 6, 12, and 24 hours post laparotomy
Analgesic effects
Assess patient's pain score post laparotomy
Measured: at 6, 12, and 24 hours post laparotomy
Dexmedetomidine side effects
Assess frequency and severity of dexmedetomidine side effects (hypotension, bradycardia)
Measured: at 6, 12, and 24 hours post laparotomy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2022
- Study start9 Dec 2019
- Primary completion8 Dec 2020
- Study completion10 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-Operative AnalgesiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yeoh Chih Nie, MMed, Principal investigator, Universiti Kebangsaan Malaysia Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05288738
- Sponsor's protocol ID
- FF-2019-543
- Status last verified
- Apr 2021
- First submitted
- 10 Mar 2022
- Last updated
- 21 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Post-Operative Analgesic Effects of Patient-Controlled Analgesia Morphine (PCAM) in Combination With Dexmedetomidine 1 mcg/ml Versus PCAM With Dexmedetomidine 2 mcg/ml
- ClinicalTrials.gov ID
- NCT05288738
- Acronym / sponsor ID
- FF-2019-543
- Keywords
- PCA Morphine, Dexmedetomidine, Morphine-dexmedetomidine, PCA-adjunct
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Universiti Kebangsaan Malaysia Medical CentreUniversity, hospital or other
- Study start
- 9 Dec 2019 (actual)
- Primary completion
- 8 Dec 2020 (actual)
- Study completion
- 10 Jan 2021 (actual)
- First posted
- 21 Mar 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This was a double-blinded prospective randomised study conducted in Universiti Kebangsaan Malaysia Medical Centre from January 2020 till November 2020. This study was approved by Dissertation Committee of the Department of Anaesthesiology and Intensive Care, Universiti Kebangsaan Malaysia Medical Centre (UKMMC) and Medical Research and Ethics Committee of UKMMC.
Consent was taken during preoperative visit whereby patients were counselled on the use of PCA machine and assessment of pain score using visual analogue scale (VAS). All patients were not given sedative premedication before surgery. Induction of general anaesthesia was with IV fentanyl 2 mcg/kg, IV propofol 2 mg/kg and paralysed with IV rocuronium 0.6 mg/kg. Patients were given IV dexamethasone 0.2 mg/kg for postoperative nausea and vomiting (PONV) prophylaxis. Anaesthesia was maintained with sevoflurane to achieve MAC of 1.0 with oxygen and air in 1:1 ratio. All patients received IV morphine 0.1mg/kg intraoperatively, and surgical site infiltrated with levobupivacaine 0.5% 2 mg/kg. IV granisetron 1 mg was given to all patients at the end of the surgery and reversal was with IV neostigmine 0.05 mg/kg and IV atropine 0.02 mg/kg.
All patients were connected to the PCA morphine with test drugs after arrival in the recovery area. Patients were encouraged to self-administer the PCA whenever required. In an event of uncontrolled pain, rescue analgesia was with IV fentanyl 20 mcg boluses. All patients upon discharged to ward from recovery bay must have pain score (VAS) of less than 4, respiratory rate more than 10, MAP > 65 mmHg and HR > 60 beats/minute.
Patients were followed up at 6, 12, and 24 hours after surgery to look at the cumulative PCA morphine usage, incidence of nausea and vomiting, sedation score, respiratory depression (respiratory rate < 10 breath/min/). Side effects from dexmedetomidine namely hypotension (MAP < 65) and bradycardia (HR < 60) were also documented. The severity of nausea and vomiting was defined as mild, moderate, or severe while sedation was assessed according to five levels: 0, 1, 2, 3 and 4.
The power calculation for this study was based on a pilot study observing PCA consumption in the first 24 hours after surgery, with a mean difference, 14.67 and pooled standard deviation 20.27 in regard to dosage delivered comparing PCA morphine with dexmedetomidine 1 mcg/ml to PCA morphine with dexmedetomidine 2 mcg/ml. A group of 34 subjects each would be needed for a study with an alpha level of 0.05 (two-tailed) and a beta level of 0.2 (80% power) including 10% dropout rate.
Data were analysed using IBMR SPSSRs Statistics MacOS version 26.0 (IBM Corporation, New York, United States of America). The results were presented as frequency (percentage) and standard deviation whenever appropriate. The cumulative PCA morphine and dexmedetomidine usage pain score was analysed using the Mann-Whitney U-test. The incidence of sedation and PONV was analysed using Chi-square. Heart rate and blood pressure were analysed using independent T-test. A probability level of < 0.05 was considered to be statistically significant.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group D1 | Active comparator | Drug: Dexmedetomidine 1 mcg/mlPCA morphine 1mg/ml |
| Group D2 | Active comparator | Drug: Dexmedetomidine 2 mcg/mlPCA morphine 1mg/ml |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- ASA 1 \& 2 patient
- going for elective or emergency laparotomy surgery
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexmedetomidine 1 mcg/mlAlso: Precedex34 patients received PCA morphine 1 mg/ml with combination of dexmedetomidine 1 mcg/ml | Drug | Group D1 |
| Dexmedetomidine 2 mcg/mlAlso: Precedex34 patients received PCA morphine 1 mg/ml with combination of dexmedetomidine 2 mcg/ml | Drug | Group D2 |
Primary outcome
Total morphine consumption
Time frame: 24 hours
Measure the total PCA morphine (mg) consumption post laparotomy
3 secondary outcomes
Morphine side effects
Time frame: at 6, 12, and 24 hours post laparotomy
Analgesic effects
Time frame: at 6, 12, and 24 hours post laparotomy
Dexmedetomidine side effects
Time frame: at 6, 12, and 24 hours post laparotomy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yeoh Chih Nie, MMed principal investigator
Universiti Kebangsaan Malaysia Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexmedetomidine 1 mcg/ml and Dexmedetomidine 2 mcg/ml in people with Post-Operative Analgesia and Opioid Use, Unspecified, run by Universiti Kebangsaan Malaysia Medical Centre at 1 site in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total morphine consumption (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Mar 2022.