Ignite Creation Date:
2024-05-06 @ 7:23 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT05996887
Status:
RECRUITING
Last Update Posted:
2023-08-21
First Post:
2023-07-29
Brief Title:
Impact of ERAS on Postoperative Nausea and Vomiting After Sleeve
Sponsor:
Minia University
Organization:
Minia University
Study Overview
Official Title:
Impact of Enhanced Recovery After Surgery ERAS for Sleeve Gastrectomy on Postoperative Nausea and Vomiting Controlled Randomized Study
Status:
RECRUITING
Status Verified Date:
2023-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The use of bariatric surgery in the treatment of severe obesity has several benefits in terms of sustainable weight loss improvements or resolution of several metabolic comorbidities as well as improved life expectancy
Gastric surgery history of acid reflux and reduction in gastric size in particular after laparoscopic sleeve gastrectomy LSG surgery may further contribute to postoperative nausea and vomiting PONV
The combination of antiemetic drugs that act at different receptors is more effective than using only one drug in preventing PONV in patients with increased risk for these events
Gastric surgery history of acid reflux and reduction in gastric size in particular after laparoscopic sleeve gastrectomy LSG surgery may further contribute to postoperative nausea and vomiting PONV
The combination of antiemetic drugs that act at different receptors is more effective than using only one drug in preventing PONV in patients with increased risk for these events
Detailed Description:
After obtaining Institutional Ethical Committee approval and written informed consent from the patients in each case the ASA score Simplified Apfel scores14 a measure of PONV risk and duration of preoperative fasting are calculated for each patient Patients will be randomly allocated into two groups
Group 1 non-ERAS All patients will receive haloperidol 2 mg dexamethasone 8 mg and ondansetron 8 mg in addition to standard care protocol
Group 2 ERAS All patients will receive haloperidol 2 mg dexamethasone 8 mg and ondansetron 8 mg in addition to following the recommendation of ERAS society guidelines
All patients will receive general anesthesia The doses of anesthetic drugs for induction and maintenance of anesthesia are calculated with reference to the ideal body weight IBW and the corrected body weight CBW in patients where IBWheight in cm-100 for men and height in cm-105 for women and CBWIBW 04 current weight-ideal weight12
Anesthesia and Operative Technique for Non-ERAS
1 Anesthesia
Induction of anesthesia IS carried out with propofol 2 mg kg -1 iv of CBW fentanyl 3 μg kg-1 CBW and cisatracurium 01 mg kg-1 iv of IBW for tracheal intubation The maintenance IS performed with fentanyl 01 to 03 μg kg-1 min -1 iv of IBW isoflurane 1 mixture of oxygen and air 11 and an additional dose of cisatracurium if necessary Neuromuscular blockade IS reversed with neostigmine up to 004 mg kg-1 IV of IBW and atropine up to 0015 mg kg-1 iv of IBW
2 Antiemetic protocol
Dexamethasone 8mg IS administered 90 min prior to induction of anesthesia
Haloperidol 2 mg after induction of anesthesia and ondansetron 8 mg IS infused 20 to 30 min prior to the end of the operation
3 Postoperative Analgesia Analgesia IS done with intravenous ketorolac 30 mg immediately after the induction of anesthesia and maintained at 8 h and acetaminophen IV 1 g every 6 h IS used in the PACU to keep PVRS4 Patient-controlled analgesia PCA containing 20 mg Nalbuphine Nalbuphine HCl 20mg 1ml to 100 ml with normal saline over 24 hours The PCA infuser unit IS infused at a rate of 2 mlh-1 with a lockout time of 15 min bolus of 1 ml per time The intensity of pain IS measured by a pain verbal rating scale PVRS 0no pain to 10worst pain12
Anesthesia and Operative Technique for ERAS
The institutional ERAS is described in Table 1 Table 1 Technique for ERAS1516 Preoperative protocols
Pain management Acetaminophen 1000mg PO 2h before anesthesia
Gabapentin 400 ml PO before anesthesia Diet Clear liquids until 3 h prior to surgery PONV prevention H2 receptor antagonist
Dexamethasone 8mg IS administered 90 min prior to induction of anesthesia Preoperative fasting
Fasting to solids until 6 h before induction and clear liquids until 2 h before induction
Intraoperative protocols
Anesthesia General anesthesia TIVA1617
Propofol 2 mg kg-1 iv of CBW GA IS maintained with iv infusion of propofol 75-150 mg kg-1 min-1
Dexmedetomidine 05 mg kg-1 iv over 10 min IS initiated and maintained with an iv infusion of dexmedetomidine 01-03 mg kg-1h-1
Ketamine a single dose before incision 05 mg kg-1 iv then 05 mgkg-1h-1
Muscle relaxation with cisatracurium 01 mg kg-1 iv of IBW IS maintained with boluses additional dose of cisatracurium if necessary Neuromuscular blockade IS reversed with neostigmine up to 004 mg kg-1 IV of IBW and atropine up to 0015 mg kg-1 iv of IBW
Patients are ventilated with a mixture of oxygen and air At the end of the surgery muscle relaxation IS reversed with neostigmine up to 5 mg and glycopyrrolate 02-08 mg
Antiemetic protocol Haloperidol 2mg IS administered immediately after induction of anesthesia and ondansetron IS infused 20 to 30 min prior to the end of the operation
Pain management Lidocaine 1 mg kg then by 1 mg kg-1 hr-1 continuous infusion 1 mg kg -1h-1 for maintenance
Magnesium Sulfate 30 mgkg continuous infusion 10 mgkgh
Bilateral Transversus Abdominis plane block TAP at the end of the operation Fluid management Goal-directed IV fluid therapy avoiding both restrictive or liberal strategies
Abdominal drainage and nasogastric decompression Nasogastric tubes and abdominal drains should not be used Postoperative protocols Pain management Bilateral Transversus Abdominis plane block TAP at the end of the operation
Lidocaine IV drip for 24 h
Acetaminophen IV transitioned to PO
Ketoralac 30 mg every 8 h
acetaminophen IV 1 g every 6 h
IV Nalbuphine breakthrough pain The intensity of pain IS measured by a pain verbal rating scale PVRS 0no pain to 10worst pain
PONV treatment Ondansetron 8 mg IS used as the primary rescue antiemetic and metoclopramide 10 mg IV IS utilized in PONV refractory to ondansetron
Thromboprophylaxis
Thromboprophylaxis should involve mechanical and pharmacological measures Doses and duration of treatment should be individualized
Fluid management Stop IV fluids on POD 1 Early postoperative nutritional care Stop IV fluids on POD 1
Clear liquids on POD 0 PO Per oral PONV postoperative nausea and vomiting IV intravenous prn when required POD postoperative day
Postoperative Care for both groups
1 Feeding A liquid diet IS prescribed for the first postoperative day followed by a diet containing broth without residue as tolerated by the patient
2 Rescue Antiemetic The PONV IS defined as at least one episode of nausea vomiting or retching PONV IS evaluated as follows I no nausea or vomiting II nausea but no vomiting III mild to moderate vomiting and IV severe and frequent vomiting more than five times within 24h
The severity of postoperative nausea PON IS assessed using a numeric rating scale I mild II moderate III severe
The severity of postoperative vomiting POV IS recorded according to the number of vomiting episodes I no vomiting II vomiting episodes occurring 1-2 times within 24 h III vomiting episodes occurring 3-5 times within 24 h IV vomiting episodes occurring more than 5 times within 24 h The volume of postoperative water intake IS measured during the two periods 0-24 h and 24-36h Nausea IS assessed hourly during the first two hours every two hours for the following four hours and every four hours until the 24th hour Nausea IS evaluated on a three-point scale from 0 no nausea 1 mild nausea to 2 severe nausea A patient IS classified to have had PONV if any nausea andor vomiting occurred within the first 24 postoperative hours
The patient IS given ondansetron IV as the primary rescue antiemetic and metoclopramide 10 mg IV IS utilized in PONV refractory to ondansetron when there IS an episode of vomiting or if there IS a request at any time made by the patient for treatment of symptoms
3 Outcome Variables Secondary endpoints included time to first administration of rescue antiemetic drug the number of rescues postoperative opioid consumption time to tolerate oral fluid and time to readiness for discharge Data collection IS done by blinded personnel at the end of the following postoperative time intervals 0-2 2-12 12-24 and 24-36 h postoperatively The quality of recovery IS assessed by QoR-1518 questionnaires at discharge In patients who are discharged before 36 h the questionnaires are filled out during a telephone call the next morning
Group 1 non-ERAS All patients will receive haloperidol 2 mg dexamethasone 8 mg and ondansetron 8 mg in addition to standard care protocol
Group 2 ERAS All patients will receive haloperidol 2 mg dexamethasone 8 mg and ondansetron 8 mg in addition to following the recommendation of ERAS society guidelines
All patients will receive general anesthesia The doses of anesthetic drugs for induction and maintenance of anesthesia are calculated with reference to the ideal body weight IBW and the corrected body weight CBW in patients where IBWheight in cm-100 for men and height in cm-105 for women and CBWIBW 04 current weight-ideal weight12
Anesthesia and Operative Technique for Non-ERAS
1 Anesthesia
Induction of anesthesia IS carried out with propofol 2 mg kg -1 iv of CBW fentanyl 3 μg kg-1 CBW and cisatracurium 01 mg kg-1 iv of IBW for tracheal intubation The maintenance IS performed with fentanyl 01 to 03 μg kg-1 min -1 iv of IBW isoflurane 1 mixture of oxygen and air 11 and an additional dose of cisatracurium if necessary Neuromuscular blockade IS reversed with neostigmine up to 004 mg kg-1 IV of IBW and atropine up to 0015 mg kg-1 iv of IBW
2 Antiemetic protocol
Dexamethasone 8mg IS administered 90 min prior to induction of anesthesia
Haloperidol 2 mg after induction of anesthesia and ondansetron 8 mg IS infused 20 to 30 min prior to the end of the operation
3 Postoperative Analgesia Analgesia IS done with intravenous ketorolac 30 mg immediately after the induction of anesthesia and maintained at 8 h and acetaminophen IV 1 g every 6 h IS used in the PACU to keep PVRS4 Patient-controlled analgesia PCA containing 20 mg Nalbuphine Nalbuphine HCl 20mg 1ml to 100 ml with normal saline over 24 hours The PCA infuser unit IS infused at a rate of 2 mlh-1 with a lockout time of 15 min bolus of 1 ml per time The intensity of pain IS measured by a pain verbal rating scale PVRS 0no pain to 10worst pain12
Anesthesia and Operative Technique for ERAS
The institutional ERAS is described in Table 1 Table 1 Technique for ERAS1516 Preoperative protocols
Pain management Acetaminophen 1000mg PO 2h before anesthesia
Gabapentin 400 ml PO before anesthesia Diet Clear liquids until 3 h prior to surgery PONV prevention H2 receptor antagonist
Dexamethasone 8mg IS administered 90 min prior to induction of anesthesia Preoperative fasting
Fasting to solids until 6 h before induction and clear liquids until 2 h before induction
Intraoperative protocols
Anesthesia General anesthesia TIVA1617
Propofol 2 mg kg-1 iv of CBW GA IS maintained with iv infusion of propofol 75-150 mg kg-1 min-1
Dexmedetomidine 05 mg kg-1 iv over 10 min IS initiated and maintained with an iv infusion of dexmedetomidine 01-03 mg kg-1h-1
Ketamine a single dose before incision 05 mg kg-1 iv then 05 mgkg-1h-1
Muscle relaxation with cisatracurium 01 mg kg-1 iv of IBW IS maintained with boluses additional dose of cisatracurium if necessary Neuromuscular blockade IS reversed with neostigmine up to 004 mg kg-1 IV of IBW and atropine up to 0015 mg kg-1 iv of IBW
Patients are ventilated with a mixture of oxygen and air At the end of the surgery muscle relaxation IS reversed with neostigmine up to 5 mg and glycopyrrolate 02-08 mg
Antiemetic protocol Haloperidol 2mg IS administered immediately after induction of anesthesia and ondansetron IS infused 20 to 30 min prior to the end of the operation
Pain management Lidocaine 1 mg kg then by 1 mg kg-1 hr-1 continuous infusion 1 mg kg -1h-1 for maintenance
Magnesium Sulfate 30 mgkg continuous infusion 10 mgkgh
Bilateral Transversus Abdominis plane block TAP at the end of the operation Fluid management Goal-directed IV fluid therapy avoiding both restrictive or liberal strategies
Abdominal drainage and nasogastric decompression Nasogastric tubes and abdominal drains should not be used Postoperative protocols Pain management Bilateral Transversus Abdominis plane block TAP at the end of the operation
Lidocaine IV drip for 24 h
Acetaminophen IV transitioned to PO
Ketoralac 30 mg every 8 h
acetaminophen IV 1 g every 6 h
IV Nalbuphine breakthrough pain The intensity of pain IS measured by a pain verbal rating scale PVRS 0no pain to 10worst pain
PONV treatment Ondansetron 8 mg IS used as the primary rescue antiemetic and metoclopramide 10 mg IV IS utilized in PONV refractory to ondansetron
Thromboprophylaxis
Thromboprophylaxis should involve mechanical and pharmacological measures Doses and duration of treatment should be individualized
Fluid management Stop IV fluids on POD 1 Early postoperative nutritional care Stop IV fluids on POD 1
Clear liquids on POD 0 PO Per oral PONV postoperative nausea and vomiting IV intravenous prn when required POD postoperative day
Postoperative Care for both groups
1 Feeding A liquid diet IS prescribed for the first postoperative day followed by a diet containing broth without residue as tolerated by the patient
2 Rescue Antiemetic The PONV IS defined as at least one episode of nausea vomiting or retching PONV IS evaluated as follows I no nausea or vomiting II nausea but no vomiting III mild to moderate vomiting and IV severe and frequent vomiting more than five times within 24h
The severity of postoperative nausea PON IS assessed using a numeric rating scale I mild II moderate III severe
The severity of postoperative vomiting POV IS recorded according to the number of vomiting episodes I no vomiting II vomiting episodes occurring 1-2 times within 24 h III vomiting episodes occurring 3-5 times within 24 h IV vomiting episodes occurring more than 5 times within 24 h The volume of postoperative water intake IS measured during the two periods 0-24 h and 24-36h Nausea IS assessed hourly during the first two hours every two hours for the following four hours and every four hours until the 24th hour Nausea IS evaluated on a three-point scale from 0 no nausea 1 mild nausea to 2 severe nausea A patient IS classified to have had PONV if any nausea andor vomiting occurred within the first 24 postoperative hours
The patient IS given ondansetron IV as the primary rescue antiemetic and metoclopramide 10 mg IV IS utilized in PONV refractory to ondansetron when there IS an episode of vomiting or if there IS a request at any time made by the patient for treatment of symptoms
3 Outcome Variables Secondary endpoints included time to first administration of rescue antiemetic drug the number of rescues postoperative opioid consumption time to tolerate oral fluid and time to readiness for discharge Data collection IS done by blinded personnel at the end of the following postoperative time intervals 0-2 2-12 12-24 and 24-36 h postoperatively The quality of recovery IS assessed by QoR-1518 questionnaires at discharge In patients who are discharged before 36 h the questionnaires are filled out during a telephone call the next morning
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None