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The goal of this randomized controlled trial is to evaluate the effectiveness of Ondansetron, Dexamethasone, and Placebo for intraoperative nausea and vomiting in patients undergoing caesarian section under spinal anesthesia. The main question it aims to answer are:
Which drug is the best at reducing the incidence of intraoperative nausea and vomiting.
Which drug is the best at reducing intraoperative pain.
Participants will be randomly divided into three groups, each will be given a different drug labelled A, B, or C.
A rating scale will be used to evaluate the severity of intraoperative nausea and pain. Episodes of vomiting will be recorded.
Data collected from the three groups will be analyzed using SPSS software.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ondansetron | Experimental | Patients given Ondansetron (8mg) |
|
| Dexamethasone | Experimental | Patients given Dexamethasone (8mg) |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ondansetron 8mg | Drug | 8mg of Ondansetron IV stat will be given to the group after induction of spinal anesthesia |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative nausea | Measured by an 11-point numeric rating scale | 20 minutes after initiation of procedure |
| Intraoperative vomiting | Number of episodes of vomiting throughout the procedure | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Intraoperative pain | Measured by an 11-point numeric rating scale | 20 minutes after the initiation of procedure |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Mubariz, MBBS | Contact | +923364241055 | mubariz1997@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Muhammad Mubariz, MBBS | House Officer | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Akhtar Saeed Trust Hospital | Lahore | Punjab Province | 53710 | Pakistan |
Patient's consent form, MR number Detailed rating scale data Intraoperative blood pressure and heart rate data
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| Dexamethasone 8mg | Drug | 8mg of Dexamethasone IV stat will be given to the group after induction of spinal anesthesia |
|
| Normal saline | Drug | Normal saline will be given IV stat to the group after induction of spinal anesthesia |
|
| ID | Term |
|---|---|
| D017294 | Ondansetron |
| D003907 | Dexamethasone |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D007093 | Imidazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D002227 | Carbazoles |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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