Postoperative AnalgesiaNCT03344393
Effect of Intraoperative IV Ketamine on Postoperative Morphine Consumption During Intestinal Surgery
A study testing Ketamine Hydrochloride and Normal saline in people with Postoperative Analgesia, run by Assiut University.
Trial summary
.The aim of this study is to identify the analgesic effect of intraoperative ketamine intravenous infusion on patients undergoing intestinal surgery and its effect on salivary cortisol and alpha amylase levels as indicator of its effect. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Analgesia
- What is being tested?
- Ketamine Hydrochloride and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2017to 1 Mar 2019
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- - Patient's status ASA status-I and II.
- Patients age above 18 years old.
- Patients scheduled for intestinal surgery.
Who cannot join
- Patient refusal.
- Patients with known allergy to ketamine or morphine.
- Patients with significant hepatic dysfunction.
- Patients with severe renal disease.
- Significant Heart disease.
- Patients with chronic pain.
Show all 15Show fewer
- Regular use analgesics, antidepressants or opioids in last 2 months.
- Any known convulsive disorder.
- Morbid obesity (BMI>35).
- Patients with autoimmune disease
- Patients on corticosteroid therapy
- Pregnancy.
- Breast feeding.
- Woman under hormonal treatment.
- Oral disease.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Effect of Intraoperative IV Ketamine on Postoperative Morphine Consumption During Intestinal Surgery and Its Effect on Salivary Cortisol and Alpha Amylase Levels
.The aim of this study is to identify the analgesic effect of intraoperative ketamine intravenous infusion on patients undergoing intestinal surgery and its effect on salivary cortisol and alpha amylase levels as indicator of its effect.
Read the detailed description
I- Group K (ketamine): 30 patients will receive intraoperative intravenous ketamine infusion.
II- Group C (control): 30 patients will receive intraoperative intravenous normal saline infusion.
- Conditions
- Postoperative Analgesia
- Being tested
- Ketamine Hydrochloride, Normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ketamine HydrochlorideDrug
Also called ketalar
intravenous ketamine infusion intraoperatively
Normal salineDrug
Also called Sodium chloride solution
intravenous normal saline infusion intraoperatively
| Study group | Role | What they receive |
|---|---|---|
| ketamine hydrochloride | Active comparator | intravenous ketamine infusion in the intraoperative period Receives: Drug: Ketamine Hydrochloride |
| normal saline | Active comparator | intravenous normal saline infusion in the intraoperative period Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption
IV PCA
Measured: 2 days postoperative
Secondary outcomes (2)
cortisol level
salivary
Measured: 2 days postoperative
alpha amylase level
salivary
Measured: 2 days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Nov 2017
- Study start1 Dec 2017 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Mar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed galal aly, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03344393
- Sponsor's protocol ID
- 17200147
- Status last verified
- Nov 2017
- First submitted
- 9 Nov 2017
- Last updated
- 17 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Arikan M, Aslan B, Arikan O, Horasanli E, But A. Comparison of the effects of magnesium and ketamine on postoperative pain and morphine consumption. A double-blind randomized controlled clinical study. Acta Cir Bras. 2016 Jan;31(1):67-73. doi: 10.1590/S0102-865020160010000010.
PubMed 26840358
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intraoperative IV Ketamine on Postoperative Morphine Consumption During Intestinal Surgery and Its Effect on Salivary Cortisol and Alpha Amylase Levels
- ClinicalTrials.gov ID
- NCT03344393
- Acronym / sponsor ID
- 17200147
- Conditions
- Postoperative Analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2017 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 17 Nov 2017 (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.
.The aim of this study is to identify the analgesic effect of intraoperative ketamine intravenous infusion on patients undergoing intestinal surgery and its effect on salivary cortisol and alpha amylase levels as indicator of its effect.
Detailed description
I- Group K (ketamine): 30 patients will receive intraoperative intravenous ketamine infusion.
II- Group C (control): 30 patients will receive intraoperative intravenous normal saline infusion.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketamine hydrochloride | Active comparator | Drug: Ketamine Hydrochlorideintravenous ketamine infusion in the intraoperative period |
| normal saline | Active comparator | Drug: Normal salineintravenous normal saline infusion in the intraoperative period |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- - Patient's status ASA status-I and II.
- Patients age above 18 years old.
- Patients scheduled for intestinal surgery.
Key exclusion criteria (15 listed)
- Patient refusal.
- Patients with known allergy to ketamine or morphine.
- Patients with significant hepatic dysfunction.
- Patients with severe renal disease.
- Significant Heart disease.
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 |
|---|---|---|
| Ketamine HydrochlorideAlso: ketalarintravenous ketamine infusion intraoperatively | Drug | ketamine hydrochloride |
| Normal salineAlso: Sodium chloride solutionintravenous normal saline infusion intraoperatively | Drug | normal saline |
Primary outcome
morphine consumption
Time frame: 2 days postoperative
IV PCA
2 secondary outcomes
cortisol level
Time frame: 2 days postoperative
alpha amylase level
Time frame: 2 days postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Nov 2017.
- Background: PubMed 26840358Arikan M, Aslan B, Arikan O, Horasanli E, But A. Comparison of the effects of magnesium and ketamine on postoperative pain and morphine consumption. A double-blind randomized controlled clinical study. Acta Cir Bras. 2016 Jan;31(1):67-73. doi: 10.1590/S0102-865020160010000010.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine Hydrochloride and Normal saline in people with Postoperative Analgesia, run by Assiut University.
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 3 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 17 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact mohamed aly, MD (00201062011126, galalm1967@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
morphine consumption (time frame: 2 days postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03344393, which also lists 1 linked publication.
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 17 Nov 2017.