Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06631625
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-10-04
Brief Title:
Effect of Addition of Dexmedetomidine or Ketamine to Intravenous Infusion of Lidocaine on Proinflammatory Cytokines in Pelvi-abdominal Cancer Surgeries
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effect of DexmedetomidineLidocaine KetamineLidocaine and Lidocaine Alone on Proinflammatory Cytokines in Pelvi-abdominal Cancer Surgeries Randomised Prospective Study
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The investigators hypothesize that effect of addition of dexmedetomidine or ketamine by IV infusion to lidocaine infusion may be more beneficial than lidocaine infusion alone on proinflammatory cytokines IL-1 IL-6 and TNFα and postoperative pain relief and decreased opioid consumption reduced Length of stay
Detailed Description:
45 female patients of American Society of Anesthesiologists ASA physical status I or II aged 40-70 years admitted to department of obstetrics and gynecology El shatby University Hospital and scheduled for elective pelvi- abdominal cancer surgery Patients will be randomly allocated using a computer generated random table Graphpad Software Inc La Jolla CA and an allocation ratio of 11 using a sealed envelope method to one of three groups The envelope will be opened by an observer not involved in the study Patients will be divided into three equal groups Group L n15 Patients will receive 15mg kg lidocaine 2 intravenously as a bolus dose then 15mgkghr lidocaine infusion using a 50cc syringe pump intra-operatively Group LK n15 Patients will receive same infusion regimen of lidocaine 2 as in group L plus 035 mgkg ketamine intravenously as a bolus dose followed by intravenous infusion of 02 mgkgh using a 50cc syringe pump intra- operatively Group LD n15 Patients will receive same infusion regimen of lidocaine 2 as in group L plus 05 μgkg dexmedetomidine intravenously as a bolus dose followed by intravenous infusion of 04 μgkgh using a 50cc syringe pump intra-operatively During preoperative visit evaluation of patients will be carried out through proper history taking clinical examination and routine laboratory investigations including complete blood picture coagulation profile blood urea serum creatinine serum electrolytes sodium potassium and calcium fasting blood glucose liver function tests and any other investigation needed
Informed written consent from all individual participants who will be included in this study will be taken during preoperative visit
The patient will be trained during preoperative visit on a visual analogue scale VAS for pain with 0 corresponding to no pain and 10 to the worst pain imaginable
Pre-anaesthetic preparation and premedication
Fasting hours 6 hours to solids and 2 hours for clear fluids
Thrombotic prophylaxis enoxaparin 40 mg will be started 12 hours before surgery
Antiseptic shower will be taken
Elastic stockings will be worn
Antibiotic prophylaxis single dose ceftriaxone 2 g intravenously will be given 1 hour before surgical incision according to hospital policy
On arrival to the operative theater
A peripheral cannula 18G will be inserted in all patients
All patients will be premedicated with intravenous IV midazolam 003 mgkg-1 shortly before anaesthesia
A multichannel monitor Dräger Infinity vista XL will be connected to the patient to display continuous electrocardiography monitoring for heart rate beatmin and rhythm noninvasive arterial blood pressure NIBP mmHg arterial oxygen saturation SpO2 and end-tidal carbon dioxide ETCO2 mmHg and nasopharyngeal core temperature oC
Patients in group L will receive an initial bolus of lidocaine 15mg kg over 10 minutes immediately before the induction of general anaesthesia then 15mgkghr lidocaine infusion in a 50cc syringe pump intra- operatively that will be stopped 30 min before end of surgery The same volume of normal saline 09 will be given intravenously over 10 minutes immediately before the induction of anaesthesia then it will be infused using a 50cc syringe pump intra-operatively in the same rate till 30 min before the end of the procedure to assure blinding
Patients in group LK will receive same infusion volume of lidocaine as in group L and 035 mgkg bolus over 10 minutes immediately before the induction of general anaesthesia followed by infusion of 02 mgkgh of ketamine intraoperatively that will be stopped 30 min before end of surgery
Patients in group LD will receive same infusion volume of lidocaine as in group L and bolus infusion of 05 μgkg over 10 min immediately before the induction of general anaesthesia 04 μgkgh continuous infusion of dexmedetomidine intraoperatively that will be stopped 30 min before end of surgery
Anaesthesia
After giving bolus doeses of the studied drugs and preoxygenation for 3 minutes standard anaesthesia will be induced in the three groups with propofol in increments up to 2mgkg till loss of verbal response fentanyl 2μgkg and atracurium 05 mgkg intravenously to facilitate tracheal intubation Anaesthesia will be maintained with 50 oxygen-air gas mixture and isoflurane 1-15 MAC to maintain adequate depth of anaesthesia The haemodynamic variables eg heart rate or blood pressure will be maintained within 20 of the preoperative baseline values by adjusting isoflurane concertration and if not patients will be treated with additional boluses of fentanyl 05 mcgkg intraoperatively as needed Mechanical ventilation will be performed with a constant tidal volume of 8 ml kg and a respiratory rate of 10 to 12 cyclesmin to maintain the end-tidal carbon dioxide tension between 35 and 40 mmHg and an oxygen saturation of 98 per cent with 50 percent oxygen in air Incremental doses of atracurium 01 mgkg will be given to maintain muscle relaxation according to nerve stimulator In all groups If the MAP drop below 60 mmHg ephedrine 5 mg IV bolus and fluid bolus will be given and repeated if required Atropine 05 mg IV bolus will be given if HR decreases to less than 50 beatsmin All patients will receive a strict fluid replacement according to the standard fluid administration guidelines during anaesthesia19
Blood transfusion will be considered only when the patients blood loss reached the transfusion point as illustrated in the following equation20 which will be determined preoperatively from the initial hematocrit by estimating blood volume and the acceptable hematocrit value will be 25
Maintain normothermia core temperature not less than 36C will be done by actively maintained using bair hugger and warm intravenous fluids
Urinary catheter will be inserted for monitoring of urine output
All the procedures will be performed by expert surgeons with a clinical experience of more than 5 years in pelvi-abdominal cancer surgeries
Patient who will require perioperative blood transfusion will be excluded from the study and will be replaced by another patient to keep the number of each group 15
At the end of surgery anaesthesia will be discontinued residual neuromuscular block will be reversed by atropine 002 mgkg and neostigmine 004 mgkg Extubation will be performed awake after the return of protective airway reflexes
Postoperative Management
All patients will be transferred to the intermediate care unit and will be closely monitored continuously for the next 24 hours by observers who will be blinded to study groups In the three groups intravenous paracetamol 1 g6 hours Perfalgan 100 ml vial UPSA France will be given for postoperative pain as standard in our institute Intravenous ketorolac 15 mg8 hours will be given for postoperative pain relief if VAS is still 4 as first postoperative rescue analgesic Fentanyl 05 mcgkg IV will be given as second postoperative rescue analgesic if VAS was 4 inspite of giving ketolac
The incidence of postoperative nausea and vomiting PONV will be assessed by a nurse for the first 24 hrs and only 2 possible answers will be accepted yes or no Nausea is defined as subjective sensation of discomfort associated with the awareness of the urge to vomit Vomiting is defined as a forceful expulsion of gastric contents through the mouth Rescue anti-emetic ondansetron 8 mg intravenously will be given if the patient has persistent nausea or more than a single episode of vomiting or whenever patients request medication
Study participants including patients attending anesthesiologists surgeons and all data collectors will be all unaware of the drug in each syringe and the master codes will be held by a person who does not participate in the observation
Informed written consent from all individual participants who will be included in this study will be taken during preoperative visit
The patient will be trained during preoperative visit on a visual analogue scale VAS for pain with 0 corresponding to no pain and 10 to the worst pain imaginable
Pre-anaesthetic preparation and premedication
Fasting hours 6 hours to solids and 2 hours for clear fluids
Thrombotic prophylaxis enoxaparin 40 mg will be started 12 hours before surgery
Antiseptic shower will be taken
Elastic stockings will be worn
Antibiotic prophylaxis single dose ceftriaxone 2 g intravenously will be given 1 hour before surgical incision according to hospital policy
On arrival to the operative theater
A peripheral cannula 18G will be inserted in all patients
All patients will be premedicated with intravenous IV midazolam 003 mgkg-1 shortly before anaesthesia
A multichannel monitor Dräger Infinity vista XL will be connected to the patient to display continuous electrocardiography monitoring for heart rate beatmin and rhythm noninvasive arterial blood pressure NIBP mmHg arterial oxygen saturation SpO2 and end-tidal carbon dioxide ETCO2 mmHg and nasopharyngeal core temperature oC
Patients in group L will receive an initial bolus of lidocaine 15mg kg over 10 minutes immediately before the induction of general anaesthesia then 15mgkghr lidocaine infusion in a 50cc syringe pump intra- operatively that will be stopped 30 min before end of surgery The same volume of normal saline 09 will be given intravenously over 10 minutes immediately before the induction of anaesthesia then it will be infused using a 50cc syringe pump intra-operatively in the same rate till 30 min before the end of the procedure to assure blinding
Patients in group LK will receive same infusion volume of lidocaine as in group L and 035 mgkg bolus over 10 minutes immediately before the induction of general anaesthesia followed by infusion of 02 mgkgh of ketamine intraoperatively that will be stopped 30 min before end of surgery
Patients in group LD will receive same infusion volume of lidocaine as in group L and bolus infusion of 05 μgkg over 10 min immediately before the induction of general anaesthesia 04 μgkgh continuous infusion of dexmedetomidine intraoperatively that will be stopped 30 min before end of surgery
Anaesthesia
After giving bolus doeses of the studied drugs and preoxygenation for 3 minutes standard anaesthesia will be induced in the three groups with propofol in increments up to 2mgkg till loss of verbal response fentanyl 2μgkg and atracurium 05 mgkg intravenously to facilitate tracheal intubation Anaesthesia will be maintained with 50 oxygen-air gas mixture and isoflurane 1-15 MAC to maintain adequate depth of anaesthesia The haemodynamic variables eg heart rate or blood pressure will be maintained within 20 of the preoperative baseline values by adjusting isoflurane concertration and if not patients will be treated with additional boluses of fentanyl 05 mcgkg intraoperatively as needed Mechanical ventilation will be performed with a constant tidal volume of 8 ml kg and a respiratory rate of 10 to 12 cyclesmin to maintain the end-tidal carbon dioxide tension between 35 and 40 mmHg and an oxygen saturation of 98 per cent with 50 percent oxygen in air Incremental doses of atracurium 01 mgkg will be given to maintain muscle relaxation according to nerve stimulator In all groups If the MAP drop below 60 mmHg ephedrine 5 mg IV bolus and fluid bolus will be given and repeated if required Atropine 05 mg IV bolus will be given if HR decreases to less than 50 beatsmin All patients will receive a strict fluid replacement according to the standard fluid administration guidelines during anaesthesia19
Blood transfusion will be considered only when the patients blood loss reached the transfusion point as illustrated in the following equation20 which will be determined preoperatively from the initial hematocrit by estimating blood volume and the acceptable hematocrit value will be 25
Maintain normothermia core temperature not less than 36C will be done by actively maintained using bair hugger and warm intravenous fluids
Urinary catheter will be inserted for monitoring of urine output
All the procedures will be performed by expert surgeons with a clinical experience of more than 5 years in pelvi-abdominal cancer surgeries
Patient who will require perioperative blood transfusion will be excluded from the study and will be replaced by another patient to keep the number of each group 15
At the end of surgery anaesthesia will be discontinued residual neuromuscular block will be reversed by atropine 002 mgkg and neostigmine 004 mgkg Extubation will be performed awake after the return of protective airway reflexes
Postoperative Management
All patients will be transferred to the intermediate care unit and will be closely monitored continuously for the next 24 hours by observers who will be blinded to study groups In the three groups intravenous paracetamol 1 g6 hours Perfalgan 100 ml vial UPSA France will be given for postoperative pain as standard in our institute Intravenous ketorolac 15 mg8 hours will be given for postoperative pain relief if VAS is still 4 as first postoperative rescue analgesic Fentanyl 05 mcgkg IV will be given as second postoperative rescue analgesic if VAS was 4 inspite of giving ketolac
The incidence of postoperative nausea and vomiting PONV will be assessed by a nurse for the first 24 hrs and only 2 possible answers will be accepted yes or no Nausea is defined as subjective sensation of discomfort associated with the awareness of the urge to vomit Vomiting is defined as a forceful expulsion of gastric contents through the mouth Rescue anti-emetic ondansetron 8 mg intravenously will be given if the patient has persistent nausea or more than a single episode of vomiting or whenever patients request medication
Study participants including patients attending anesthesiologists surgeons and all data collectors will be all unaware of the drug in each syringe and the master codes will be held by a person who does not participate in the observation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None