Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery
NCT07914868, Phase 4, Not yet recruiting, Assiut University
Trial 10
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
| Field | Value | Source |
|---|---|---|
| Title | Effect of Ondansetron on the Incidence of Spinal Anaesthesia-Induced Hypotension in Elderly Patients Undergoing Fracture Hip Surgery | ClinicalTrials.gov |
| NCT number | NCT07914868 | ClinicalTrials.gov |
| Status | Not yet recruiting | ClinicalTrials.gov |
| Phases | Phase 4 | ClinicalTrials.gov |
| Enrollment | 142 participants, estimated | ClinicalTrials.gov |
| Lead sponsor | Assiut University | ClinicalTrials.gov |
| Conditions | Spinal Anaesthesia Induced Hypotension | ClinicalTrials.gov |
| Interventions | Ondansetron, 0.9% Normal Saline placebo | ClinicalTrials.gov |
| First posted | 2026-11-04 | ClinicalTrials.gov |
| Last updated | 2026-11-04 | ClinicalTrials.gov |
Registered outcomes 9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description | Source |
|---|---|---|---|---|
| Primary | Effect of prophylactic intravenous ondansetron versus Placebo on the incidence of spinal anaesthesia-induced hypotension | 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. | ClinicalTrials.gov |
| Secondary | The incidence of severe hypotension | From induction of spinal anaesthesia until completion of surgery. | Severe hypotension, defined as systolic blood pressure (SBP) dropping to \<60% of baseline | ClinicalTrials.gov |
| Secondary | The number of episodes of intraoperative hypotension. | From induction of spinal anaesthesia until completion of surgery. | 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 | ClinicalTrials.gov |
| Secondary | The incidence of bradycardia | From induction of spinal anaesthesia until completion of surgery. | The Percentage of people who experience Bradycardia, defined as heart rate (HR) \<50 bpm, intraoperatively | ClinicalTrials.gov |
| Secondary | The total rescue vasopressor (ephedrine) and atropine requirements between groups | From induction of spinal anaesthesia until completion of surgery. | Total dose of intraoperative ephedrine or atropine if hypotension or bradycardia occurs | ClinicalTrials.gov |
| Secondary | The incidence of postoperative nausea and vomiting (PONV) | Up to 24 hours postoperatively | 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. | ClinicalTrials.gov |
| Secondary | The incidence of intraoperative and postoperative shivering between groups | From induction of spinal anaesthesia up to 24 hours postoperatively | Assess the presence of shivering intraoperatively and postoperatively | ClinicalTrials.gov |
| Secondary | Sensory block characteristics (onset and duration) between groups. | From induction of spinal anaesthesia until completion of surgery. | 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. | ClinicalTrials.gov |
| Secondary | Motor block characteristics (onset, Modified Bromage score, and duration) between groups. | From induction of spinal anaesthesia until completion of surgery. | 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. | ClinicalTrials.gov |
Outcomes 0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as | Source |
|---|
Results by group 0
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units | Source |
|---|
Participant flow 0
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted | Source |
|---|
Adverse events 0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events | Source |
|---|
Adverse event totals 0
The totals the trial posted for each group.
| Total | Group | Affected | At risk | Source |
|---|
Papers 9
The papers the trial lists on ClinicalTrials.gov.
Grants 0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
| Project | Title | Principal investigators | Organization | Funder | Fiscal years | Source |
|---|
Trial comparisons 0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|
Tests 0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|
Source 5
| Field | Value | Source |
|---|---|---|
| Release | trials-2026-11-12-0.4.0 | ClinicalTrials.gov |
| Release manifest SHA-256 | 0f4a8d8c48aee2a7573ae0fa94ecbeab70c1adbe449bbc95c424bc7d3e97b9d4 | ClinicalTrials.gov |
| Registry capture | 2026-11-12 | ClinicalTrials.gov |
| Results copy, AACT | 2026-03-23 | ClinicalTrials.gov |
| NIH clinical studies file | 2026-11-13 | ClinicalTrials.gov |
Release trials-2026-11-12-0.4.0
ClinicalTrials.gov's posted results, through CTTI's AACT: ClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299 ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
ClinicalTrials.gov: none stated ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
NIH RePORTER's clinical studies and project files: Public domain (NIH RePORTER)