Post-spinal HypotensionNCT06995690
Ketamine for Preventing Post-Spinal Hypotension in Orthopedic Surgery
A study testing Ketamine and Normal Saline in people with Post-spinal Hypotension and Orthopedic Surgery, run by Ain Shams University at 1 site in Egypt.
Trial summary
This randomized, double-blind, controlled clinical trial investigates the efficacy of a sub-anesthetic dose of ketamine (0.5 mg/kg IV) in preventing post-spinal hypotension in patients undergoing elective orthopedic surgeries under spinal anesthesia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post-spinal Hypotension, Orthopedic Surgery, Spinal Aneshtesia
- What is being tested?
- Ketamine and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2025to 1 Nov 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patients American Society of Anesthesiologists Physical Status (ASA) I to II undergoing orthopedic surgeries under spinal anesthesia.
- Both Sexes.
- Patients aged equal to or above 18 years.
- Body mass index <35 kg/m2
- Duration of operation from 1 hour to 3 hours
Who cannot join
- Patients' refusal of procedure or participation in the study.
- Patients with contraindication to spinal anesthesia.
- Patients with cardiovascular or pulmonary disease.
- Patients with pre-procedural hypotension (systolic arterial pressure less than 90 mmHg and/or mean arterial pressure less than 60 mmHg).
- Patients aged below 18 years.
- Duration of operation below 1 hour or above 3 hours.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mohammed S Shorbagy, M.D contact
About this study
Official title: Impact of Sub-anesthetic Dose of Ketamine in the Prevention of Post Spinal Hypotension in Patients Undergoing Orthopedic Surgeries
This randomized, double-blind, controlled clinical trial investigates the efficacy of a sub-anesthetic dose of ketamine (0.5 mg/kg IV) in preventing post-spinal hypotension in patients undergoing elective orthopedic surgeries under spinal anesthesia. The study compares ketamine with placebo (normal saline) in terms of blood pressure stability and incidence of hypotensive episodes following spinal anesthesia.
Read the detailed description
Spinal anesthesia is commonly used for orthopedic procedures due to its effectiveness and favorable recovery profile. However, spinal-induced hypotension is a frequent complication resulting from sympathetic blockade, which can compromise organ perfusion and increase perioperative risk. This study aims to determine whether a single sub-anesthetic dose of intravenous ketamine administered before spinal anesthesia can reduce the incidence of hypotension.
Patients will be randomly allocated to either a ketamine group (receiving 0.5 mg/kg ketamine IV diluted in Ringer's lactate) or a control group (receiving volume-equivalent normal saline). Both interventions are administered over 20 minutes prior to the spinal injection to ensure blinding. All patients will undergo standard spinal anesthesia with 0.5% heavy bupivacaine plus fentanyl.
Primary outcome is the incidence of hypotension (defined as a mean arterial pressure drop >20% from baseline). Secondary outcomes include bradycardia, nausea, vomiting, hallucinations, and total dose of vasopressors required. The findings aim to support or refute the use of ketamine as a prophylactic strategy to stabilize hemodynamics during spinal anesthesia.
- Being tested
- Ketamine, Normal Saline
- Keywords
- Ketamine, Sub-anesthetic dose, Hypotension prevention, Neuraxial anesthesia, Hemodynamic stability, regional anesthesia, ASA I-II, Double-blind randomized trial, Blood pressure monitoring, Ephedrine use
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetamineDrug
Patients receive crystalloid preloading of 15ml/kg (Ringer's lactate) +the sub-anesthetic dose of ketamine of 0.5 mg/kg IV added to the first bottle of ringer for blinding over 20 min before the spinal injection.
Normal SalineDrug
Patients receive a crystalloid preloading of 15 ml/kg (Ringer's lactate)+ 0.5 mg/kg IV of Normal Saline added to the first bottle of ringer for blinding, over 20 min before the spinal injection.
| Study group | Role | What they receive |
|---|---|---|
| Ketamine Group | Experimental | Patients receive crystalloid preloading of 15ml/kg (Ringer's lactate) +the sub-anesthetic dose of ketamine of 0.5 mg/kg IV added to the first bottle of ringer for blinding over 20 min before the spinal injection. Receives: Drug: Ketamine |
| Control Group | Placebo comparator | Patients receive a crystalloid preloading of 15 ml/kg (Ringer's lactate)+ 0.5 mg/kg IV of Normal Saline added to the first bottle of ringer for blinding, over 20 min before the spinal injection. Receives: Drug: Normal Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Post-Spinal Hypotension
Hypotension is defined as a mean arterial pressure (MAP) less than 20% below baseline. MAP will be calculated using the formula: MAP = DBP + (SBP - DBP)/3.
Hypotension will be treated with boluses of IV Ephedrine (3mg) and repeated if needed. The total dose of ephedrine required to correct hypotension and raise the MAP to the baseline will be recorded.
Measured: From spinal injection to end of surgery
Secondary outcomes (3)
Incidence of Hallucinations
Visual or auditory disturbances post ketamine administration. Midazolam (2 mg IV) will be given pre-injection to mitigate risk.
Measured: From spinal injection to end of surgery
Incidence of Bradycardia
Bradycardia is defined as Heart Rate less than 50 beats per minute. Bradycardia will be treated with IV atropine (0.04 mg/kg) and repeated if needed.
Measured: From spinal injection to end of surgery
Incidence of Nausea and Vomiting
Nausea is defined as an unpleasant subjective urge to vomit and Vomiting is defined as propulsive abdominal muscular spasms associated with the expulsion of gastric contents.
Nausea and vomiting will be treated with 3 mg IV Granisetron.
Measured: From spinal injection to end of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start1 Jun 2025
- Primary completion1 Oct 2025 (estimated)
- Study completion1 Nov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post-spinal HypotensionStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Reem H El Kabarity, M.D, Principal investigator, Faculty of Medicine, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06995690
- Sponsor's protocol ID
- FMASU MS 70/2025
- Status last verified
- May 2025
- First submitted
- 21 May 2025
- Last updated
- 18 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This is an academic study with a limited sample size, and there is no current plan to share de-identified participant data publicly.
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Sub-anesthetic Dose of Ketamine in the Prevention of Post Spinal Hypotension in Patients Undergoing Orthopedic Surgeries
- ClinicalTrials.gov ID
- NCT06995690
- Acronym / sponsor ID
- FMASU MS 70/2025
- Keywords
- Ketamine, Sub-anesthetic dose, Hypotension prevention, Neuraxial anesthesia, Hemodynamic stability, regional anesthesia, ASA I-II, Double-blind randomized trial
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Oct 2025 (estimated)
- Study completion
- 1 Nov 2025 (estimated)
- First posted
- 29 May 2025 (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.
This randomized, double-blind, controlled clinical trial investigates the efficacy of a sub-anesthetic dose of ketamine (0.5 mg/kg IV) in preventing post-spinal hypotension in patients undergoing elective orthopedic surgeries under spinal anesthesia. The study compares ketamine with placebo (normal saline) in terms of blood pressure stability and incidence of hypotensive episodes following spinal anesthesia.
Detailed description
Spinal anesthesia is commonly used for orthopedic procedures due to its effectiveness and favorable recovery profile. However, spinal-induced hypotension is a frequent complication resulting from sympathetic blockade, which can compromise organ perfusion and increase perioperative risk. This study aims to determine whether a single sub-anesthetic dose of intravenous ketamine administered before spinal anesthesia can reduce the incidence of hypotension.
Patients will be randomly allocated to either a ketamine group (receiving 0.5 mg/kg ketamine IV diluted in Ringer's lactate) or a control group (receiving volume-equivalent normal saline). Both interventions are administered over 20 minutes prior to the spinal injection to ensure blinding. All patients will undergo standard spinal anesthesia with 0.5% heavy bupivacaine plus fentanyl.
Primary outcome is the incidence of hypotension (defined as a mean arterial pressure drop >20% from baseline). Secondary outcomes include bradycardia, nausea, vomiting, hallucinations, and total dose of vasopressors required. The findings aim to support or refute the use of ketamine as a prophylactic strategy to stabilize hemodynamics during spinal anesthesia.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ketamine Group | Experimental | Drug: KetaminePatients receive crystalloid preloading of 15ml/kg (Ringer's lactate) +the sub-anesthetic dose of ketamine of 0.5 mg/kg IV added to the first bottle of ringer for blinding over 20 min before the spinal injection. |
| Control Group | Placebo comparator | Drug: Normal SalinePatients receive a crystalloid preloading of 15 ml/kg (Ringer's lactate)+ 0.5 mg/kg IV of Normal Saline added to the first bottle of ringer for blinding, over 20 min before the spinal injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients American Society of Anesthesiologists Physical Status (ASA) I to II undergoing orthopedic surgeries under spinal anesthesia.
- Both Sexes.
- Patients aged equal to or above 18 years.
- Body mass index <35 kg/m2
- Duration of operation from 1 hour to 3 hours
Key exclusion criteria (6 listed)
- Patients' refusal of procedure or participation in the study.
- Patients with contraindication to spinal anesthesia.
- Patients with cardiovascular or pulmonary disease.
- Patients with pre-procedural hypotension (systolic arterial pressure less than 90 mmHg and/or mean arterial pressure less than 60 mmHg).
- Patients aged below 18 years.
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 |
|---|---|---|
| KetaminePatients receive crystalloid preloading of 15ml/kg (Ringer's lactate) +the sub-anesthetic dose of ketamine of 0.5 mg/kg IV added to the first bottle of ringer for blinding over 20 min before the spinal injection. | Drug | Ketamine Group |
| Normal SalinePatients receive a crystalloid preloading of 15 ml/kg (Ringer's lactate)+ 0.5 mg/kg IV of Normal Saline added to the first bottle of ringer for blinding, over 20 min before the spinal injection. | Drug | Control Group |
Primary outcome
Incidence of Post-Spinal Hypotension
Time frame: From spinal injection to end of surgery
Hypotension is defined as a mean arterial pressure (MAP) less than 20% below baseline. MAP will be calculated using the formula: MAP = DBP + (SBP - DBP)/3. Hypotension will be treated with boluses of IV Ephedrine (3mg) and repeated if needed. The total dose of ephedrine required to correct hypotension and raise the MAP to the baseline will be recorded.
3 secondary outcomes
Incidence of Hallucinations
Time frame: From spinal injection to end of surgery
Incidence of Bradycardia
Time frame: From spinal injection to end of surgery
Incidence of Nausea and Vomiting
Time frame: From spinal injection to end of surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2025.
- Individual participant dataSharing planned: No. This is an academic study with a limited sample size, and there is no current plan to share de-identified participant data publicly.
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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.
Mohammed S Shorbagy, M.D contact
Reem H El Kabarity, M.D principal investigator
Faculty of Medicine, Ain Shams University
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 and Normal Saline in people with Post-spinal Hypotension and Orthopedic Surgery, run by Ain Shams 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 5 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: looking for participants now, as of the sponsor's last update on 18 Jun 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amira G Abdelmoniem Abdalla, M.B.B.Ch. (+201277719693, am.ga.ab.ab.mo@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Post-Spinal Hypotension (time frame: From spinal injection to end of surgery). 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 18 Jun 2025.