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The goal of this clinical trial is to learn if Dextrose 10% or superhydration works to prevent postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy.
. The main questions it aims to answer are:
Does Dextrose 10% or superhydration lower the number of times participants gets an episode of nausea and vomititng after laparoscopic cholecystectomy surgery? Researchers will compare Dextrose 10% versus superhydration to a placebo (a look-alike substance that contains no drug) to see if glucose 10% or superhydation can work to prevent postoperative nausea and vomiting.
Participants will:
Take Dextrose 10% or superhydration or a placebo in the operation monitored for 4 hours after surgery to check on their nausea and vomiting state
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Superhydration group receiving 20 ml/kg | Active Comparator | Group Ringer Lactate planned to receive ringer lactate 20 ml/kg over the first 90 to 120 minutes |
|
| Dextrose group receiving Dextrose 10% | Experimental | Group Dextrose planned to receive Dextrose 10% 250 ml over 60 minutes added to 3 ml/kg/Hr ringer lactate as intraoperative fluid maintenance |
|
| control group receiving 3ml/kg/hr | No Intervention | Group control planned to receive ringer lactate with rate 3ml /kg /Hr as intraoperative fluid maintenance added to the loading dose according to Ain Shams Anesthesia and Critical care department protocol |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ringer lactate (20ml/kg) | Drug | ringer lactate 20 ml/kg over the first 90 to 120 minutes after induction intraoperatively |
|
| Measure | Description | Time Frame |
|---|---|---|
| To compare the incidence of Post operative nausea and vomiting in the study treatment groups | Postoperative 4 hours stay in PACU |
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of vomiting episodes | Postoperative 4 hours stay in PACU | |
| Measurement of PONV severity scores | Severity of PONV was assessed using a 4-point Verbal Descriptive Scale (VDS) which consists of: Score 0= no PONV: no complaint of nausea or vomiting; Score 1= mild PONV: patient complains from nausea but doesn't need antiemetic treatment. Score 2= moderate PONV: patient complains from nausea and need antiemetic treatment; Score 3= severe PONV: patient complains from nausea with episode of vomiting requiring antiemetic treatment. PONV scores were obtained every half hour |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aya H. M. Ahmad, Assistant professor, MD | Ain Shams University Faculty of Medicine | Principal Investigator |
| Wael A. M. Abdelwahab, Assistant professor, MD | Ain Shams University Faculty of Medicine | Principal Investigator |
| Mohamed A. Elgendy, Assistant professor, MD | Ain Shams University Faculty of Medicine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Medicine Ain Shams University | Cairo | Abbassia | 11591 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34041090 | Result | Stephenson SJ, Jiwanmall M, Cherian NE, Kamakshi S, Williams A. Reduction in post-operative nausea and vomiting (PONV) by preoperative risk stratification and adherence to a standardized anti emetic prophylaxis protocol in the day-care surgical population. J Family Med Prim Care. 2021 Feb;10(2):865-870. doi: 10.4103/jfmpc.jfmpc_1692_20. Epub 2021 Feb 27. |
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The IPD that will be shared will be Age, Sex, BMI, ASA score , operation duration and anesthesia duration , PONV severity score, nausea and vomiting frequency , total antiemetic usage intra and postoperative in the PACU and time needed to discharge from the PACU
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| Dextrose 10% | Drug | Dextrose 10% 250 ml over 60 minutes |
|
| Postoperative 4 hours stay in PACU |
| Time from extubation till discharge from PACU | From the moment of extubation till the moment of discharge from PACU with patient being completely vitally stable and nausea and vomiting free , assessed to be from 4 to 8 hours |
| total antiemetic medication consumption | Severity of PONV was assessed using a 4-point Verbal Descriptive Scale (VDS) which consists of: Score 0= no PONV: no complaint of nausea or vomiting; Score 1= mild PONV: patient complains from nausea but doesn't need antiemetic treatment. Score 2= moderate PONV: patient complains from nausea and need antiemetic treatment; Score 3= severe PONV: patient complains from nausea with episode of vomiting requiring antiemetic treatment. PONV scores were obtained every half hour, Rescue antiemetic granisetron 1 mg IV was given when VDS scores were 2 or more. Medications were given only after excluding other causes of PONV such as hypovolemia, hypotension, hypoxia. The total number of doses of antiemetics used were obtained every half hour from the time of entry to the PACU for 4 hours | Postoperative period 4 hours stay in PACU. ( if the patient needed to stay for longer duration in the PACU for any medical reason then any antiemetic used in this period will be recorded as well ) |
| ID | Term |
|---|---|
| D020250 | Postoperative Nausea and Vomiting |
| D009325 | Nausea |
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| D000077325 | Ringer's Lactate |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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