Hemodynamic InstabilityNCT05865080
Effect of Intravenous Ketamine Infusion for Hemodynamic Stability in Patients Undergoing Caesarean Delivery.
A study testing Ketamine in people with Hemodynamic Instability, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Hypotension is the most frequent side effect of intrathecal anesthesia, with a found incidence of more than 80%. With a frequency of between 40% and 60% in patients undergoing surgery, Perioperative shivering is a serious consequence that frequently follows neuraxial anesthesia. Read more about this study
- Who is it for?
- Ages 21 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hemodynamic Instability
- What is being tested?
- Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 126 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2022to 1 Feb 2023
- 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 21 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female patients and full-term,
- aged between (21 and 40) y. Old.
- (ASA)-II or III, and undergoing a cesarean section.
Who cannot join
- Twins and preterm birth.
- Hypertensive patients and preeclamptic patients.
- Morbidly obese patients.
- Spinal anesthesia contraindication as the patient refused, severe mitral or tricuspid stenosis and local sepsis.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Intravenous Ketamine Infusion for Hemodynamic Stability in Patients Undergoing Cesarean Delivery
Hypotension is the most frequent side effect of intrathecal anesthesia, with a found incidence of more than 80%. With a frequency of between 40% and 60% in patients undergoing surgery, Perioperative shivering is a serious consequence that frequently follows neuraxial anesthesia. This study aimed to determine the multiple advantages of intravenous minimal dose ketamine for intrathecal anesthesia in patients undergoing cesarean delivery
Read the detailed description
126 female patients undergoing cesarean deliveries, ASA-(II and III) and 21-40 ys old selected from an attendee of outpatient clinics of the Anesthesia Department. Two groups of patients were random to group K (63 patients): Received 0.3 mg/kg of ketamine IV diluted to 10 ml followed by infusion 0.1 mg/kg/hr. as 20 ml solution, group C (Controlled) (63 patients): Received 10 ml of normal saline followed by infusion of 0.1 ml/kg/hr. as 20 ml solution.
- Conditions
- Hemodynamic Instability
- Being tested
- Ketamine, Placebo
- Keywords
- spinal anesthesia, obstetric anesthesia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
0.3 mg/kg of ketamine IV diluted to 10 ml followed by infusion 0.1 mg/kg/hr. as 20 ml solution before spinal anesthesia
PlaceboDrug
Normal saline
| Study group | Role | What they receive |
|---|---|---|
| group K | Active comparator | group K (63 patients): Received 0.3 mg/kg of ketamine IV diluted to 10 ml followed by infusion 0.1 mg/kg/hr. as 20 ml solution, Receives: Drug: Ketamine |
| group C | Placebo comparator | group C (Controlled) (63 patients): Received 10 ml of normal saline followed by infusion of 0.1 ml/kg/hr. as 20 ml solution. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hemodynamics
Primary outcomes: Hemodynamic parameters (MAP and HR). Secondary outcomes
- Incidence of intraoperative shivering.
- The postoperative pain was assessed by VAS score.
- Sedation score in between groups.
- Fetus evaluated by Apgar score.
- Postoperative side effects as nausea, vomiting, nystagmus, diplopia, and hallucinations.
Measured: Up to 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2023
- Study start1 Jul 2022
- Primary completion1 Jan 2023
- Study completion1 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hemodynamic InstabilityStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohamed, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05865080
- Sponsor's protocol ID
- 12345
- Status last verified
- May 2023
- First submitted
- 18 Apr 2023
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Ketamine Infusion for Hemodynamic Stability in Patients Undergoing Cesarean Delivery
- ClinicalTrials.gov ID
- NCT05865080
- Acronym / sponsor ID
- 12345
- Conditions
- Hemodynamic Instability
- Keywords
- spinal anesthesia, obstetric anesthesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Feb 2023 (actual)
- First posted
- 18 May 2023 (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.
Hypotension is the most frequent side effect of intrathecal anesthesia, with a found incidence of more than 80%. With a frequency of between 40% and 60% in patients undergoing surgery, Perioperative shivering is a serious consequence that frequently follows neuraxial anesthesia. This study aimed to determine the multiple advantages of intravenous minimal dose ketamine for intrathecal anesthesia in patients undergoing cesarean delivery
Detailed description
126 female patients undergoing cesarean deliveries, ASA-(II and III) and 21-40 ys old selected from an attendee of outpatient clinics of the Anesthesia Department. Two groups of patients were random to group K (63 patients): Received 0.3 mg/kg of ketamine IV diluted to 10 ml followed by infusion 0.1 mg/kg/hr. as 20 ml solution, group C (Controlled) (63 patients): Received 10 ml of normal saline followed by infusion of 0.1 ml/kg/hr. as 20 ml solution.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group K | Active comparator | Drug: Ketaminegroup K (63 patients): Received 0.3 mg/kg of ketamine IV diluted to 10 ml followed by infusion 0.1 mg/kg/hr. as 20 ml solution, |
| group C | Placebo comparator | Drug: Placebogroup C (Controlled) (63 patients): Received 10 ml of normal saline followed by infusion of 0.1 ml/kg/hr. as 20 ml solution. |
Who may qualify
- Ages
- 21 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Female patients and full-term,
- aged between (21 and 40) y. Old.
- (ASA)-II or III, and undergoing a cesarean section.
Key exclusion criteria (4 listed)
- Twins and preterm birth.
- Hypertensive patients and preeclamptic patients.
- Morbidly obese patients.
- Spinal anesthesia contraindication as the patient refused, severe mitral or tricuspid stenosis and local sepsis.
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 |
|---|---|---|
| Ketamine0.3 mg/kg of ketamine IV diluted to 10 ml followed by infusion 0.1 mg/kg/hr. as 20 ml solution before spinal anesthesia | Drug | group K |
| PlaceboNormal saline | Drug | group C |
Primary outcome
Hemodynamics
Time frame: Up to 24 hours after operation
Primary outcomes: Hemodynamic parameters (MAP and HR). Secondary outcomes 1. Incidence of intraoperative shivering. 2. The postoperative pain was assessed by VAS score. 3. Sedation score in between groups. 4. Fetus evaluated by Apgar score. 5. Postoperative side effects as nausea, vomiting, nystagmus, diplopia, and hallucinations.
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 22 May 2023.
- Individual participant dataSharing planned: Undecided
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Dexametedomidine Ketamine Infusion Versus Dexametedomidine Propofol Infusion in Non-compliant Agitated Patients on Continuous Positive Airway Pressure (CPAP) Mask Ventilation in the Intensive Care Unit
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ketamine in people with Hemodynamic Instability, run by Al-Azhar University at 1 site in Egypt.
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 4 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 22 May 2023. 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 Egypt. 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. Some participants in this study may receive a placebo. 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?
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?
Hemodynamics (time frame: Up to 24 hours after operation). 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 22 May 2023; AzTrials last refreshed its copy on 8 Nov 2026.