adjusted to keep the HR and mean arterial blood pressure within 20% of the pre induction values. Starting from the induction till the end of the operation.
Comparison Between Low-dose Ketamine Infusion and Intravenous Morphine
Brief Summary
Ketamine is an antagonist of N-methyl-d-aspartate (NMDA) receptor that not only abolishes peripheral afferent noxious stimulation, but it may also prevent central sensitization of nociceptors as shown in animal studies with excellent analgesic property even in subanesthetic doses. It is readily available and is being used currently, even by non-Anesthesiologists, to provide "sedation" for minor procedures.(.. Low-dose ketamine infusion in the perioperative period has shown to produce analgesia and decrease the requirements of opioid analgesics.. In obstetrics, it is being used as an adjunct to an inadequately functioning spinal anesthesia for caesarean section, as an induction agent for cesarean section and also to provide analgesia during labor in intermittent boluses.
Intervention / Treatment
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Ketamine group: (DRUG)Ketamine group: will be administered ketamine in a loading dose of 0.2 mg/kg over 5 min pre incision followed-by an infusion at 0.2 mg/kg/h until the end of surgery.
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Control group (DRUG)where normal saline was administered as a loading dose then infused with same rate of another group, throughout the whole surgery.
Condition or Disease
- Ketamine
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years to 50 Years |
| Enrollment: | 80 (ACTUAL) |
| Funded by: | Other |
| Allocation: | Randomized |
| Primary Purpose: | Diagnostic |
MaskingDOUBLE:
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Clinical Trial Dates
| Start date: | Feb 21, 2019 | ACTUAL |
|---|---|---|
| Primary Completion: | May 20, 2020 | ACTUAL |
| Completion Date: | Jun 20, 2020 | ACTUAL |
| Study First Posted: | Feb 24, 2020 | ACTUAL |
| Results First Posted: | Aug 31, 2020 | |
| Last Updated: | Jul 28, 2020 |
Sponsors / Collaborators
Lead Sponsor:
Cairo University
Responsible Party:
N/A
Location
Ketamine is an antagonist of N-methyl-d-aspartate (NMDA) receptor that not only abolishes peripheral afferent noxious stimulation, but it may also prevent central sensitization of nociceptors as shown in animal studies with excellent analgesic property even in subanesthetic doses. It is readily available and is being used currently, even by non-Anesthesiologists, to provide "sedation" for minor procedures.(.. Low-dose ketamine infusion in the perioperative period has shown to produce analgesia and decrease the requirements of opioid analgesics.. In obstetrics, it is being used as an adjunct to an inadequately functioning spinal anesthesia for caesarean section, as an induction agent for cesarean section and also to provide analgesia during labor in intermittent boluses.
Participant Groups
-
control group: where normal saline will be administered as a loading dose then infused with same rate of another group, throughout the whole surgery.
-
Ketamine group: will be administered ketamine in a loading dose of 0.2 mg/kg over 5 min pre incision followed-by an infusion at 0.2 mg/kg/h until the end of surgery.
Eligibility Criteria
| Sex: | Female |
|---|---|
| Minimum Age: | 18 |
| Maximum Age: | 50 |
| Age Groups: | Adult |
| Healthy Volunteers: | Yes |
Inclusion criteria:
The study will include 80 ASA physical status I, II patients with age between 18- 50 years old scheduled for elective myomectomy under general anesthesia
Exclusion criteria:
Patients who refused to participate, ASA physical status III, IV, patients younger than 18 years or \> 50 years old, BMI \> 30, history of epilepsy. Patients having a history of parenteral or oral analgesics within the last 24 hours before initiation of operation or those having allergy to study agents will be excluded.
-
The study will include 80 ASA physical status I, II patients with age between 18- 50 years old scheduled for elective myomectomy under general anesthesia
Exclusion criteria:
Patients who refused to participate, ASA physical status III, IV, patients younger than 18 years or \> 50 years old, BMI \> 30, history of epilepsy. Patients having a history of parenteral or oral analgesics within the last 24 hours before initiation of operation or those having allergy to study agents will be excluded.
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Primary Outcomes
Secondary Outcomes
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time from start to end
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assessment of patient by VAS sore 0= no pain , 10= sever pain
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complication
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complication
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complication
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complication
More Details
| NCT Number: | NCT04281628 |
|---|---|
| Other IDs: | I-190414 |
| Study URL: | https://clinicaltrials.gov/study/NCT04281628 |
Last updated: Sep 29, 2023