Spinal Anaesthesia Induced HypotensionPhase 4NCT07914868
Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
A Phase 4 study testing Ondansetron in people with Spinal Anaesthesia Induced Hypotension, run by Assiut University at 1 site in Egypt.
Trial summary
This study aims to compare prophylactic intravenous ondansetron 4 mg versus placebo regarding the incidence of spinal anaesthesia-induced hypotension, defined as mean arterial pressure (MAP) fall >20% from baseline or systolic blood pressure (SBP) <90 mmHg/fall >20% from baseline, in elderly patients undergoing… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Spinal Anaesthesia Induced Hypotension
- What is being tested?
- Ondansetron
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2026to Mar 2029
- Phase
- Phase 4
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Age ≥ 65 years
- American Society of Anesthesiologists (ASA) physical status I, II, III (according to the American Society of Anesthesiologists classification).
- Scheduled for elective hip fracture surgery under spinal anaesthesia.
Who cannot join
- Patient refusal or inability to provide informed consent.
- Contraindication to spinal/neuraxial anaesthesia (coagulopathy, local infection at injection site, patient refusal, severe spinal deformity).
- Known hypersensitivity or contraindication to ondansetron (e.g., congenital long-QT syndrome).
- Baseline cardiac arrhythmia, significant conduction abnormality, or QTc > 450-470 ms on preoperative ECG.
- Severe cardiovascular disease (decompensated heart failure, recent myocardial infarction, severe valvular disease), ASA IV-V.
- Baseline bradycardia (heart rate < 50 bpm) or use of a permanent pacemaker.
Show all 9Show fewer
- Concurrent use of medications that significantly affect heart rate or QT interval (e.g., class III antiarrhythmics), or of another 5-HT3 antagonist within 24 hours.
- Emergency surgery, or planned combined spinal-general anaesthesia/conversion anticipated.
- Pregnancy (not applicable in most cases given the population) and cognitive impairment precluding valid consent or symptom reporting.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery: A Randomized, Double-Blind, Controlled Clinical Trial
This study aims to compare prophylactic intravenous ondansetron 4 mg versus placebo regarding the incidence of spinal anaesthesia-induced hypotension, defined as mean arterial pressure (MAP) fall >20% from baseline or systolic blood pressure (SBP) <90 mmHg/fall >20% from baseline, in elderly patients undergoing fracture hip surgery. The hypothesis is that a significant difference exists.
Read the detailed description
Spinal anesthesia is widely used for fracture hip surgery because it provides effective surgical anesthesia while avoiding many physiological effects associated with general anesthesia. However, spinal anesthesia-induced hypotension (SIH), defined as a mean arterial pressure (MAP) decrease >20% from baseline or systolic blood pressure (SBP) <90 mmHg or a >20% decrease from baseline, is one of its most common complications. It primarily results from sympathetic blockade, causing vasodilation, reduced venous return, decreased cardiac output, and subsequent arterial hypotension. This may be particularly significant in elderly patients because of reduced cardiovascular, arterial, and autonomic reserve, together with a higher prevalence of cardiovascular disease and polypharmacy.
A sudden reduction in left-ventricular preload may activate cardiac mechanoreceptors and trigger the Bezold-Jarisch reflex (BJR). Serotonin-sensitive 5-HT3 receptors located on intracardiac vagal nerve endings may enhance vagal activity, contributing to bradycardia defined as heart rate (HR) < 50 beat per minute (bpm) and hypotension.
Ondansetron, a selective 5-HT3 receptor antagonist widely used as an antiemetic, has been investigated to attenuate the BJR and reduce SIH. Several randomized trials and meta-analyses have reported that prophylactic intravenous ondansetron, commonly given at 4-8 mg shortly before spinal injection, reduces post-spinal hypotension, bradycardia, and rescue vasopressor requirements, including in elderly surgical patients. An exploratory analysis suggested a greater preventive effect in patients aged ≥65 years.
However, the elderly subgroup was small and a 8 mg dose was used, leaving uncertainty regarding the optimal dose.
Spinal anesthesia technique The conduct of spinal anesthesia will be standardized across the two groups. On arrival to the operating room, standard ASA monitors including a pulse oximetry, electrocardiography and non-invasive blood pressure will be applied and the patients will be continuously monitored.
Baseline hemodynamics will be recorded at one, three, and five minutes before the studied drug administration, and the average will be taken as a baseline.
After an intravenous (IV) access is secured, all patients will receive an intraoperative infusion of 5-10 ml/kg Ringer's lactate or Normal saline solution per hour.
With the parturient in a sitting position, spinal anaesthesia will be conducted using the midline or paramedian approach after proper antiseptic cleaning and draping in the lumbar vertebral interspace of L3-L4 or a level below using a 25 or 22-gauge Quincke needle. After confirming free flow of cerebrospinal fluid, a 3 mL of hyperbaric bupivacaine 0.5% will be injected intrathecal in both Groups the same dose, Then all patients will be then made to lie supine.
Block-level will be tested every five minutes using a frozen plastic ampule of sterile water along the midclavicular line to check the response to cold, and the highest sensory level obtained will be registered.
Motor level will be assessed every five minutes using the Modified Bromage Scale, where Grade 0 indicates full movement of the hip, knee, and ankle; Grade 1 indicates inability to raise the extended leg while retaining the ability to flex the knee and move the ankle; Grade 2 indicates inability to flex the knee while retaining ankle movement; and Grade 3 indicates complete motor block with inability to move the hip, knee, or ankle. The highest Modified Bromage grade obtained will be recorded.
Surgeons will be allowed to proceed with surgery after attaining a block level of at least up to T10.
Data collection
- Patient characteristics including, age, sex, weight, height, and ASA status.
- Hemodynamic parameters including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and oxygen saturation (SpO2) will be recorded at the following time points:
- Before injection of the study drug (baseline);
- At interval of 0 (baseline) and 5 minutes after the study drug administration and before intrathecal injection;
- At two-minutes intervals up to 20 minutes after intrathecal injection,
- Every 5 minutes until end of surgery.
- Postoperative hemodynamics at 2, 4, 6, 8, 12, 24 hours after surgery.
- Bradycardia (HR <50 bpm) will be treated with atropine 0.5 mg. Clinically significant hypotension, defined as MAP fall > 20% from baseline, or systolic blood pressure < 90 mmHg / fall > 20% from baseline, and if developed will be treated with IV ephedrine sulfate boluses of 6 mg as required. Amount of atropine and ephedrine required, sensory level achieved at 15 min of Spinal anaesthesia.
- Duration of surgery (minutes), total fluid intake (ml), and length of PACU stay (minutes).
- Side effects including hypotension (defined as MAP fall > 20% from baseline, or systolic blood pressure < 90 mmHg / fall > 20% from baseline), hypertension, bradycardia (HR < 50 bpm), tachycardia (HR > 100 bpm), hypoxemia (defined as a SpO2 level of less than 94% with a need for oxygen supplementation), respiratory depression, hallucinations, nystagmus, postoperative nausea and vomiting (PONV), and shivering will be treated and recorded.
The incidence of postoperative nausea and vomiting (PONV) episodes will be assessed in the first 24 h (at 2, 4, 6, 8, 12, 24 hours after surgery).
Patients who will develop shivering will be warmed with heated blankets.
- Conditions
- Spinal Anaesthesia Induced Hypotension
- Being tested
- Ondansetron, 0.9% Normal Saline placebo
- Keywords
- spinal anaesthesia, Spinal anaesthesia induced hypotension, Ondansetron, elderly patients, hip surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OndansetronDrug
4 mg diluted in 10 mL 0.9% normal saline.
0.9% Normal Saline placeboDrug
10 mL IV 0.9% normal saline
| Study group | Role | What they receive |
|---|---|---|
| Group O (Ondansetron) | Experimental | Ondansetron 4 mg diluted in 10 mL 0.9% normal saline over 60-90 seconds prior to spinal injection Receives: Drug: Ondansetron |
| Group P (Placebo) | Placebo comparator | IV bolus of 10 mL 0.9% normal saline over 60-90 seconds prior to spinal injection Receives: Drug: 0.9% Normal Saline placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of prophylactic intravenous ondansetron versus Placebo on the incidence of spinal anaesthesia-induced hypotension
Compare the effect of prophylactic intravenous ondansetron 4 mg versus Placebo on the incidence of spinal anaesthesia-induced hypotension, defined as MAP fall > 20% from baseline, or systolic blood pressure < 90 mmHg / fall > 20% from baseline, in elderly patients undergoing fracture hip surgery under spinal anaesthesia.
Measured: From induction of spinal anaesthesia until completion of surgery.
Secondary outcomes (8)
The incidence of severe hypotension
Severe hypotension, defined as systolic blood pressure (SBP) dropping to <60% of baseline
Measured: From induction of spinal anaesthesia until completion of surgery.
The number of episodes of intraoperative hypotension.
The percentage of people who experience hypotension, defined as MAP fall > 20% from baseline, or systolic blood pressure < 90 mmHg / fall > 20% from baseline, intraoperatively
Measured: From induction of spinal anaesthesia until completion of surgery.
The incidence of bradycardia
The Percentage of people who experience Bradycardia, defined as heart rate (HR) <50 bpm, intraoperatively
Measured: From induction of spinal anaesthesia until completion of surgery.
The total rescue vasopressor (ephedrine) and atropine requirements between groups
Total dose of intraoperative ephedrine or atropine if hypotension or bradycardia occurs
Measured: From induction of spinal anaesthesia until completion of surgery.
The incidence of postoperative nausea and vomiting (PONV)
PONV was evaluated using the PONV grading scale in the post-anesthesia care unit (PACU) at 2, 4, 6, 8, 12, and 24 hours
PONV will be assessed using a four-grade scale: Grade 0 indicates no PONV; Grade I indicates nausea without vomiting; Grade II indicates nausea with vomiting occurring fewer than three times per day; and Grade III indicates vomiting occurring three or more times per day.
Measured: Up to 24 hours postoperatively
The incidence of intraoperative and postoperative shivering between groups
Assess the presence of shivering intraoperatively and postoperatively
Measured: From induction of spinal anaesthesia up to 24 hours postoperatively
Sensory block characteristics (onset and duration) between groups.
Block-level will be tested every five minutes using a frozen plastic ampule of sterile water along the midclavicular line to check the response to cold, and the highest sensory level obtained will be recorded Surgeons will be allowed to proceed with surgery after attaining a block level of at least T10.
Measured: From induction of spinal anaesthesia until completion of surgery.
Motor block characteristics (onset, Modified Bromage score, and duration) between groups.
Motor level will be assessed every five minutes using the Modified Bromage Scale, where Grade 0 indicates full movement of the hip, knee, and ankle; Grade 1 indicates inability to raise the extended leg while retaining the ability to flex the knee and move the ankle; Grade 2 indicates inability to flex the knee while retaining ankle movement; and Grade 3 indicates complete motor block with inability to move the hip, knee, or ankle. The highest Modified Bromage grade obtained will be recorded.
Surgeons will be allowed to proceed with surgery after attaining a block level of at least T10.
Measured: From induction of spinal anaesthesia until completion of surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2026
- Study start1 Dec 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Spinal Anaesthesia Induced HypotensionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mina Nagy Shoukrallah, Assiut University
- Investigators
- Sherif Sayyed Abdelrahem, PhD, Study chair, Assiut UniversityAbdelrahman Hamdy Mohamed, PhD, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07914868
- Sponsor's protocol ID
- 04-2026-201911
- Status last verified
- Nov 2026
- First submitted
- 28 Oct 2026
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Hou XM, Chen YJ, Lai L, Liu K, Shen QH. Ondansetron Reduces the Incidence of Hypotension after Spinal Anaesthesia: A Systematic Review and Meta-Analysis. Pharmaceuticals (Basel). 2022 Dec 19;15(12):1588. doi: 10.3390/ph15121588.
PubMed 36559039Mohamed SA, Hussam AM, Abdallah SA, Sarhan KA, Shaban AM. Ondansetron Is an Effective Alternative to Decrease the Incidence of Postspinal Hypotension in Healthy Subjects Undergoing Infra-Umbilical Surgeries Compared To Combined Volume Loading and Vasoconstrictors: Randomized Controlled Trial. Open Access Maced J Med Sci. 2018 Dec 19;6(12):2363-2368. doi: 10.3889/oamjms.2018.491. eCollection 2018 Dec 20.
PubMed 30607192Marashi SM, Soltani-Omid S, Soltani Mohammadi S, Aghajani Y, Movafegh A. Comparing Two Different Doses of Intravenous Ondansetron With Placebo on Attenuation of Spinal-induced Hypotension and Shivering. Anesth Pain Med. 2014 Mar 18;4(2):e12055. doi: 10.5812/aapm.12055. eCollection 2014 May.
PubMed 24790900Mendonca FT, Crepaldi Junior LC, Gersanti RC, de Araujo KC. Effect of ondansetron on spinal anesthesia-induced hypotension in non-obstetric surgeries: a randomised, double-blind and placebo-controlled trial. Braz J Anesthesiol. 2021 May-Jun;71(3):233-240. doi: 10.1016/j.bjane.2020.12.028. Epub 2021 Mar 22.
PubMed 33766681Tatikonda CM, Rajappa GC, Rath P, Abbas M, Madhapura VS, Gopal NV. Effect of Intravenous Ondansetron on Spinal Anesthesia-Induced Hypotension and Bradycardia: A Randomized Controlled Double-Blinded Study. Anesth Essays Res. 2019 Apr-Jun;13(2):340-346. doi: 10.4103/aer.AER_22_19.
PubMed 31198257Abbas N, Shah SA, Naqvi SS. Role of prophylactic ondansetron for prevention of spinal anaesthesia induced hypotension in lower segment caesarean section. Pakistan Armed Forces Medical Journal. 2016 Dec 1(6):790. https://pafmj.org/index.php/PAFMJ/article/download/927/777
Qin R, Xu X, Zhao N, Shi Y, Chen Y, Chen J, Ni X. Effect of different prophylactical doses of ondansetron for the hemodynamic stability in patients undergoing cesarean section: a randomized controlled study. Front Med (Lausanne). 2025 Apr 3;12:1495721. doi: 10.3389/fmed.2025.1495721. eCollection 2025.
PubMed 40248081Xie F, Sun DF, Yang L, Sun ZL. Effect of anesthesia induction with butorphanol on postoperative nausea and vomiting: A randomized controlled trial. World J Clin Cases. 2023 Nov 16;11(32):7806-7813. doi: 10.12998/wjcc.v11.i32.7806.
PubMed 380736868. Rashad MM, Farmawy MS. Effects of intravenous ondansetron and granisetron on hemodynamic changes and motor and sensory blockade induced by spinal anesthesia in parturients undergoing cesarean section. Egypt J Anaesth. 2013;29(4):369-374. doi:10.1016/j.egja.2013.04.004. Doi link https://doi.org/10.1016/j.egja.2013.04.004
Sahoo T, SenDasgupta C, Goswami A, Hazra A. Reduction in spinal-induced hypotension with ondansetron in parturients undergoing caesarean section: a double-blind randomised, placebo-controlled study. Int J Obstet Anesth. 2012 Jan;21(1):24-8. doi: 10.1016/j.ijoa.2011.08.002. Epub 2011 Nov 18.
PubMed 22100822Owczuk R, Wenski W, Twardowski P, Dylczyk-Sommer A, Sawicka W, Wujtewicz MA, Marciniak A, Polak-Krzeminska A, Jasinski T, Wujtewicz M. Ondansetron attenuates the decrease in blood pressure due to spinal anesthesia in the elderly: a double blind, placebo-controlled study. Minerva Anestesiol. 2015 Jun;81(6):598-607.
PubMed 25220555
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery: A Randomized, Double-Blind, Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07914868
- Acronym / sponsor ID
- 04-2026-201911
- Conditions
- Spinal Anaesthesia Induced Hypotension
- Keywords
- spinal anaesthesia, Spinal anaesthesia induced hypotension, Ondansetron, elderly patients, hip surgery
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 4 Nov 2026 (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 study aims to compare prophylactic intravenous ondansetron 4 mg versus placebo regarding the incidence of spinal anaesthesia-induced hypotension, defined as mean arterial pressure (MAP) fall >20% from baseline or systolic blood pressure (SBP) <90 mmHg/fall >20% from baseline, in elderly patients undergoing fracture hip surgery. The hypothesis is that a significant difference exists.
Detailed description
Spinal anesthesia is widely used for fracture hip surgery because it provides effective surgical anesthesia while avoiding many physiological effects associated with general anesthesia. However, spinal anesthesia-induced hypotension (SIH), defined as a mean arterial pressure (MAP) decrease >20% from baseline or systolic blood pressure (SBP) <90 mmHg or a >20% decrease from baseline, is one of its most common complications. It primarily results from sympathetic blockade, causing vasodilation, reduced venous return, decreased cardiac output, and subsequent arterial hypotension. This may be particularly significant in elderly patients because of reduced cardiovascular, arterial, and autonomic reserve, together with a higher prevalence of cardiovascular disease and polypharmacy.
A sudden reduction in left-ventricular preload may activate cardiac mechanoreceptors and trigger the Bezold-Jarisch reflex (BJR). Serotonin-sensitive 5-HT3 receptors located on intracardiac vagal nerve endings may enhance vagal activity, contributing to bradycardia defined as heart rate (HR) < 50 beat per minute (bpm) and hypotension.
Ondansetron, a selective 5-HT3 receptor antagonist widely used as an antiemetic, has been investigated to attenuate the BJR and reduce SIH. Several randomized trials and meta-analyses have reported that prophylactic intravenous ondansetron, commonly given at 4-8 mg shortly before spinal injection, reduces post-spinal hypotension, bradycardia, and rescue vasopressor requirements, including in elderly surgical patients. An exploratory analysis suggested a greater preventive effect in patients aged ≥65 years.
However, the elderly subgroup was small and a 8 mg dose was used, leaving uncertainty regarding the optimal dose.
Spinal anesthesia technique The conduct of spinal anesthesia will be standardized across the two groups. On arrival to the operating room, standard ASA monitors including a pulse oximetry, electrocardiography and non-invasive blood pressure will be applied and the patients will be continuously monitored.
Baseline hemodynamics will be recorded at one, three, and five minutes before the studied drug administration, and the average will be taken as a baseline.
After an intravenous (IV) access is secured, all patients will receive an intraoperative infusion of 5-10 ml/kg Ringer's lactate or Normal saline solution per hour.
With the parturient in a sitting position, spinal anaesthesia will be conducted using the midline or paramedian approach after proper antiseptic cleaning and draping in the lumbar vertebral interspace of L3-L4 or a level below using a 25 or 22-gauge Quincke needle. After confirming free flow of cerebrospinal fluid, a 3 mL of hyperbaric bupivacaine 0.5% will be injected intrathecal in both Groups the same dose, Then all patients will be then made to lie supine.
Block-level will be tested every five minutes using a frozen plastic ampule of sterile water along the midclavicular line to check the response to cold, and the highest sensory level obtained will be registered.
Motor level will be assessed every five minutes using the Modified Bromage Scale, where Grade 0 indicates full movement of the hip, knee, and ankle; Grade 1 indicates inability to raise the extended leg while retaining the ability to flex the knee and move the ankle; Grade 2 indicates inability to flex the knee while retaining ankle movement; and Grade 3 indicates complete motor block with inability to move the hip, knee, or ankle. The highest Modified Bromage grade obtained will be recorded.
Surgeons will be allowed to proceed with surgery after attaining a block level of at least up to T10.
Data collection
- Patient characteristics including, age, sex, weight, height, and ASA status.
- Hemodynamic parameters including heart rate (HR), systolic blood pressure (SBP), diastolic blood pressure (DBP), mean arterial pressure (MAP) and oxygen saturation (SpO2) will be recorded at the following time points:
- Before injection of the study drug (baseline);
- At interval of 0 (baseline) and 5 minutes after the study drug administration and before intrathecal injection;
- At two-minutes intervals up to 20 minutes after intrathecal injection,
- Every 5 minutes until end of surgery.
- Postoperative hemodynamics at 2, 4, 6, 8, 12, 24 hours after surgery.
- Bradycardia (HR <50 bpm) will be treated with atropine 0.5 mg. Clinically significant hypotension, defined as MAP fall > 20% from baseline, or systolic blood pressure < 90 mmHg / fall > 20% from baseline, and if developed will be treated with IV ephedrine sulfate boluses of 6 mg as required. Amount of atropine and ephedrine required, sensory level achieved at 15 min of Spinal anaesthesia.
- Duration of surgery (minutes), total fluid intake (ml), and length of PACU stay (minutes).
- Side effects including hypotension (defined as MAP fall > 20% from baseline, or systolic blood pressure < 90 mmHg / fall > 20% from baseline), hypertension, bradycardia (HR < 50 bpm), tachycardia (HR > 100 bpm), hypoxemia (defined as a SpO2 level of less than 94% with a need for oxygen supplementation), respiratory depression, hallucinations, nystagmus, postoperative nausea and vomiting (PONV), and shivering will be treated and recorded.
The incidence of postoperative nausea and vomiting (PONV) episodes will be assessed in the first 24 h (at 2, 4, 6, 8, 12, 24 hours after surgery).
Patients who will develop shivering will be warmed with heated blankets.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group O (Ondansetron) | Experimental | Drug: OndansetronOndansetron 4 mg diluted in 10 mL 0.9% normal saline over 60-90 seconds prior to spinal injection |
| Group P (Placebo) | Placebo comparator | Drug: 0.9% Normal Saline placeboIV bolus of 10 mL 0.9% normal saline over 60-90 seconds prior to spinal injection |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (3 listed)
- Age ≥ 65 years
- American Society of Anesthesiologists (ASA) physical status I, II, III (according to the American Society of Anesthesiologists classification).
- Scheduled for elective hip fracture surgery under spinal anaesthesia.
Key exclusion criteria (9 listed)
- Patient refusal or inability to provide informed consent.
- Contraindication to spinal/neuraxial anaesthesia (coagulopathy, local infection at injection site, patient refusal, severe spinal deformity).
- Known hypersensitivity or contraindication to ondansetron (e.g., congenital long-QT syndrome).
- Baseline cardiac arrhythmia, significant conduction abnormality, or QTc > 450-470 ms on preoperative ECG.
- Severe cardiovascular disease (decompensated heart failure, recent myocardial infarction, severe valvular disease), ASA IV-V.
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 |
|---|---|---|
| Ondansetron4 mg diluted in 10 mL 0.9% normal saline. | Drug | Group O (Ondansetron) |
| 0.9% Normal Saline placebo10 mL IV 0.9% normal saline | Drug | Group P (Placebo) |
Primary outcome
Effect of prophylactic intravenous ondansetron versus Placebo on the incidence of spinal anaesthesia-induced hypotension
Time frame: From induction of spinal anaesthesia until completion of surgery.
Compare the effect of prophylactic intravenous ondansetron 4 mg versus Placebo on the incidence of spinal anaesthesia-induced hypotension, defined as MAP fall > 20% from baseline, or systolic blood pressure < 90 mmHg / fall > 20% from baseline, in elderly patients undergoing fracture hip surgery under spinal anaesthesia.
8 secondary outcomes
The incidence of severe hypotension
Time frame: From induction of spinal anaesthesia until completion of surgery.
The number of episodes of intraoperative hypotension.
Time frame: From induction of spinal anaesthesia until completion of surgery.
The incidence of bradycardia
Time frame: From induction of spinal anaesthesia until completion of surgery.
The total rescue vasopressor (ephedrine) and atropine requirements between groups
Time frame: From induction of spinal anaesthesia until completion of surgery.
The incidence of postoperative nausea and vomiting (PONV)
Time frame: Up to 24 hours postoperatively
The incidence of intraoperative and postoperative shivering between groups
Time frame: From induction of spinal anaesthesia up to 24 hours postoperatively
Sensory block characteristics (onset and duration) between groups.
Time frame: From induction of spinal anaesthesia until completion of surgery.
Motor block characteristics (onset, Modified Bromage score, and duration) between groups.
Time frame: From induction of spinal anaesthesia until completion 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 4 Nov 2026.
- Background: PubMed 36559039Hou XM, Chen YJ, Lai L, Liu K, Shen QH. Ondansetron Reduces the Incidence of Hypotension after Spinal Anaesthesia: A Systematic Review and Meta-Analysis. Pharmaceuticals (Basel). 2022 Dec 19;15(12):1588. doi: 10.3390/ph15121588.
- Background: PubMed 30607192Mohamed SA, Hussam AM, Abdallah SA, Sarhan KA, Shaban AM. Ondansetron Is an Effective Alternative to Decrease the Incidence of Postspinal Hypotension in Healthy Subjects Undergoing Infra-Umbilical Surgeries Compared To Combined Volume Loading and Vasoconstrictors: Randomized Controlled Trial. Open Access Maced J Med Sci. 2018 Dec 19;6(12):2363-2368. doi: 10.3889/oamjms.2018.491. eCollection 2018 Dec 20.
- Background: PubMed 24790900Marashi SM, Soltani-Omid S, Soltani Mohammadi S, Aghajani Y, Movafegh A. Comparing Two Different Doses of Intravenous Ondansetron With Placebo on Attenuation of Spinal-induced Hypotension and Shivering. Anesth Pain Med. 2014 Mar 18;4(2):e12055. doi: 10.5812/aapm.12055. eCollection 2014 May.
- Background: PubMed 33766681Mendonca FT, Crepaldi Junior LC, Gersanti RC, de Araujo KC. Effect of ondansetron on spinal anesthesia-induced hypotension in non-obstetric surgeries: a randomised, double-blind and placebo-controlled trial. Braz J Anesthesiol. 2021 May-Jun;71(3):233-240. doi: 10.1016/j.bjane.2020.12.028. Epub 2021 Mar 22.
- Background: PubMed 31198257Tatikonda CM, Rajappa GC, Rath P, Abbas M, Madhapura VS, Gopal NV. Effect of Intravenous Ondansetron on Spinal Anesthesia-Induced Hypotension and Bradycardia: A Randomized Controlled Double-Blinded Study. Anesth Essays Res. 2019 Apr-Jun;13(2):340-346. doi: 10.4103/aer.AER_22_19.
- BackgroundAbbas N, Shah SA, Naqvi SS. Role of prophylactic ondansetron for prevention of spinal anaesthesia induced hypotension in lower segment caesarean section. Pakistan Armed Forces Medical Journal. 2016 Dec 1(6):790. https://pafmj.org/index.php/PAFMJ/article/download/927/777
- Background: PubMed 40248081Qin R, Xu X, Zhao N, Shi Y, Chen Y, Chen J, Ni X. Effect of different prophylactical doses of ondansetron for the hemodynamic stability in patients undergoing cesarean section: a randomized controlled study. Front Med (Lausanne). 2025 Apr 3;12:1495721. doi: 10.3389/fmed.2025.1495721. eCollection 2025.
- Background: PubMed 38073686Xie F, Sun DF, Yang L, Sun ZL. Effect of anesthesia induction with butorphanol on postoperative nausea and vomiting: A randomized controlled trial. World J Clin Cases. 2023 Nov 16;11(32):7806-7813. doi: 10.12998/wjcc.v11.i32.7806.
- Background8. Rashad MM, Farmawy MS. Effects of intravenous ondansetron and granisetron on hemodynamic changes and motor and sensory blockade induced by spinal anesthesia in parturients undergoing cesarean section. Egypt J Anaesth. 2013;29(4):369-374. doi:10.1016/j.egja.2013.04.004. Doi link https://doi.org/10.1016/j.egja.2013.04.004
- Background: PubMed 22100822Sahoo T, SenDasgupta C, Goswami A, Hazra A. Reduction in spinal-induced hypotension with ondansetron in parturients undergoing caesarean section: a double-blind randomised, placebo-controlled study. Int J Obstet Anesth. 2012 Jan;21(1):24-8. doi: 10.1016/j.ijoa.2011.08.002. Epub 2011 Nov 18.
- Background: PubMed 25220555Owczuk R, Wenski W, Twardowski P, Dylczyk-Sommer A, Sawicka W, Wujtewicz MA, Marciniak A, Polak-Krzeminska A, Jasinski T, Wujtewicz M. Ondansetron attenuates the decrease in blood pressure due to spinal anesthesia in the elderly: a double blind, placebo-controlled study. Minerva Anestesiol. 2015 Jun;81(6):598-607.
- Individual participant dataSharing planned: Undecided
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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.
Sherif Sayyed Abdelrahem, PhD study chair
Assiut University
Abdelrahman Hamdy Mohamed, PhD study director
Assiut University
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 Ondansetron in people with Spinal Anaesthesia Induced Hypotension, run by Assiut 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 9 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: opening soon, as of the sponsor's last update on 4 Nov 2026. 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.
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?
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 Mina Nagy Shoukrallah, M.B.B.Ch. (+201271107782, menanagy396@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effect of prophylactic intravenous ondansetron versus Placebo on the incidence of spinal anaesthesia-induced hypotension (time frame: From induction of spinal anaesthesia until completion of surgery.). 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 NCT07914868, which also lists 11 linked publications.
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 4 Nov 2026.