Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2016-02-29
2016-10-31
Brief Summary
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Detailed Description
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All patients will be preoxygenated with 100% oxygen for 3 minutes. The patients in group D will receive dexmedetomidine (2 ml diluted in 18 ml of saline) IV in a dose of 1 mcg/kg over10 minutes through infusion pump prior to induction. Group P patients will receive similar volume of normal saline over 10 min. The study drug and placebo infusions will be prepared by an anesthesiologist who is not involved in the study and the anesthesiologist recording the details is unaware of the type of infusion patients received. Anesthesia will be induced with IV fentanyl 1.5 μg/kg and propofol in a dose of 10 mg every 5 seconds until the BIS level dropped below 60 and confirmed with loss of response to verbal commands. In both groups, Atracurium 0.5 mg/kg IV will be administered, and trachea will be intubated. Fresh gas flow oxygen in air 30-40% at a rate of 3 L/min for 10 minutes will be administered then the flow will be decreased at a rate of 1 L/min using a closed system (Fabius GS, Dräger, Lübeck, Germany) and ventilation will be adjusted to maintain end-tidal carbon dioxide at 30-35 mmHg. Patients in study groups will receive the volatile agent at a concentration of 1 MAC (Minimum Alveolar Concentration). The MAC of desflurane is defined as an expired fraction of 6.0 vol%. Then the dial-up desflurane percentage will be adjusted to establish a BIS value between 40- 50. A maintenance dose of Dexmedetomidine infusion at 0.5 mcg/kg/hour made to 20 mL with normal saline will be administered in group D patients and a similar volume of normal saline will be administered in Group P, till the end of surgery. Top up doses of Atracurium will be given as needed. When heart rate and blood pressure exceeds 20% of baseline in spite of adequate level of anesthesia guided by BIS, boluses of 0.5 μg/kg will be given. While decrease in heart rate and blood pressure more than 20% of baseline, will be treated by ephedrine 5 mg.
In both groups, dexmedetomidine or saline will be stopped approximately 15-20 minutes before completion of surgery, diclofenac sodium 1 mg/kg will be given IM at the time of skin closure. Desflurane will be discontinued after skin closure in both groups. Reversal of neuromuscular blockade will be achieved with neostigmine 0.05 mg/kg and atropine 0.02 mg/kg. Tracheal extubation will be done when respiration is satisfactory and adequate muscle tone is achieved
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Group 'D'
Dexmedetomidine group Patients received dexmedetomidine (2 ml diluted in 18 ml of saline) IV in a dose of 1 mcg/kg over 10 minutes. A maintenance dose of Dexmedetomidine infusion at 0.5 mcg/kg/hour was infused.
Ondansetron: 0.15 mg/kg intravenous preoperative. Fentanyl: 1.5 μg/kg intraoperative Propofol: 10 mg every 5 seconds until the BIS level dropped below 60 for induction of anesthesia.
Atracurium: 0.5 mg/kg IV. Desflurane: 1 MAC concentration. Diclofenac sodium: 1 mg/kg for postoperative analgesia.
Dexmedetomidine
A maintenance dose of Dexmedetomidine infusion at 0.5 mcg/kg/hour made to 20 mL with normal saline will be administered
Ondansetron
0.15 mg/kg intravenous (IV) will be given as a pre-medication
fentanyl
1.5 μg/kg intraoperative
propofol
10 mg every 5 seconds until the BIS level dropped below 60 for induction of anesthesia
Atracurium
0.5 mg/kg IV for endotracheal intubation
diclofenac sodium
1 mg/kg for postoperative analgesia
desflurane
1 MAC concentration (expired fraction of 6.0 vol%) for maintenance of anesthesia
Group 'P'
Placebo group Patients received similar volume of normal saline as the bolus and maintenance infusion as group D.
Ondansetron: 0.15 mg/kg intravenous preoperative. Fentanyl: 1.5 μg/kg intraoperative Propofol: 10 mg every 5 seconds until the BIS level dropped below 60 for induction of anesthesia.
Atracurium: 0.5 mg/kg IV. Desflurane: 1 MAC concentration. Diclofenac sodium: 1 mg/kg for postoperative analgesia.
Placebo
A maintenance dose of 20 mL with normal saline will be administered at a rate similar to that of dexmedetomidine
Ondansetron
0.15 mg/kg intravenous (IV) will be given as a pre-medication
fentanyl
1.5 μg/kg intraoperative
propofol
10 mg every 5 seconds until the BIS level dropped below 60 for induction of anesthesia
Atracurium
0.5 mg/kg IV for endotracheal intubation
diclofenac sodium
1 mg/kg for postoperative analgesia
desflurane
1 MAC concentration (expired fraction of 6.0 vol%) for maintenance of anesthesia
Interventions
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Dexmedetomidine
A maintenance dose of Dexmedetomidine infusion at 0.5 mcg/kg/hour made to 20 mL with normal saline will be administered
Placebo
A maintenance dose of 20 mL with normal saline will be administered at a rate similar to that of dexmedetomidine
Ondansetron
0.15 mg/kg intravenous (IV) will be given as a pre-medication
fentanyl
1.5 μg/kg intraoperative
propofol
10 mg every 5 seconds until the BIS level dropped below 60 for induction of anesthesia
Atracurium
0.5 mg/kg IV for endotracheal intubation
diclofenac sodium
1 mg/kg for postoperative analgesia
desflurane
1 MAC concentration (expired fraction of 6.0 vol%) for maintenance of anesthesia
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* undergoing elective laparoscopic cholecystectomy
Exclusion Criteria
* cardiovascular disease
* morbid obese patients
* pregnant and nursing women
* known allergic reaction to any of the study medication
* recent use of sedatives or analgesics
15 Years
50 Years
ALL
No
Sponsors
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Theodor Bilharz Research Institute
OTHER
Responsible Party
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Yasser Mostafa Samhan
Professor of Anesthesia
Principal Investigators
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Abla El Hadidy, PhD
Role: STUDY_DIRECTOR
Theodor Bilharz Research Institute
Locations
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Theodor Bilharz Research Institute
Giza, , Egypt
Countries
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References
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Harsoor SS, Rani DD, Lathashree S, Nethra SS, Sudheesh K. Effect of intraoperative Dexmedetomidine infusion on Sevoflurane requirement and blood glucose levels during entropy-guided general anesthesia. J Anaesthesiol Clin Pharmacol. 2014 Jan;30(1):25-30. doi: 10.4103/0970-9185.125693.
Kamibayashi T, Maze M. Clinical uses of alpha2 -adrenergic agonists. Anesthesiology. 2000 Nov;93(5):1345-9. doi: 10.1097/00000542-200011000-00030. No abstract available.
Nishibe S, Imanishi H, Mieda T, Tsujita M. The effects of dexmedetomidine administration on the pulmonary artery pressure and the transpulmonary pressure gradient after the bidirectional superior cavopulmonary shunt. Pediatr Cardiol. 2015 Jan;36(1):151-7. doi: 10.1007/s00246-014-0979-2. Epub 2014 Aug 12.
Other Identifiers
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Anesthesia 110T
Identifier Type: -
Identifier Source: org_study_id