Dexmedetomidine and Desflurane Consumption

Effect of Dexmedetomidine Infusion on Desflurane Consumption and Hemodynamics During BIS Guided Laparoscopic Surgery: A Randomized Controlled Study

The aim of this study is to calculate desflurane consumption when combined with intraoperative dexmedetomidine infusion guided by bispectral index (BIS)

Study Overview

• Status: Completed
• Conditions: Anesthesia
• Intervention / Treatment: Drug: Dexmedetomidine; Procedure: Ondansetron; Procedure: fentanyl; Procedure: propofol; Procedure: Atracurium; Procedure: diclofenac sodium; Procedure: desflurane; Drug: Placebo

Detailed Description

Forty patients will be randomly allocated into two equal groups as Group 'D' (Dexmedetomidine group) and Group 'P' (Placebo group) using computer generated random numbers. After arrival in the operating room, ondansetron 0.15 mg/kg intravenous (IV) will be given as a pre-medication. Ringer's acetate solution (500 ml) will be infused as a preload then at a rate of 6-8 ml/kg/h during surgery for supplying maintenance and deficit. Monitoring consisted of continuous electrocardiogram (EKG), non-invasive blood pressure (NIBP), pulse oximetry (SpO2), CO2 expired fraction (ETCO2), desflurane inspired fraction (FIdes), and desflurane expired fraction (ETdes) (Infinity Kappa, Dräger, Lübeck, Germany) will be attached to the patient. BIS module (InfinityR BISxTM SmartPodR, smoothing rate: 15 or 30 seconds, software revision: VF5) will also be attached for detection of consciousness level.

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

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Giza, Egypt, 12411
    • Theodor Bilharz Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 13 years to 48 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• American Society of Anesthesiologists (ASA) status of I and II
• undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

• history of psychiatric/neurological illness
• cardiovascular disease
• morbid obese patients
• pregnant and nursing women
• known allergic reaction to any of the study medication
• recent use of sedatives or analgesics

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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.	Drug: Dexmedetomidine; A maintenance dose of Dexmedetomidine infusion at 0.5 mcg/kg/hour made to 20 mL with normal saline will be administered; Other Names: Precedex; Dexdor; Procedure: Ondansetron; 0.15 mg/kg intravenous (IV) will be given as a pre-medication; Other Names: Zofran; Procedure: fentanyl; 1.5 μg/kg intraoperative; Other Names: Sublimaze,Actiq, Durogesic, Duragesic; Procedure: propofol; 10 mg every 5 seconds until the BIS level dropped below 60 for induction of anesthesia; Other Names: Diprivan; Procedure: Atracurium; 0.5 mg/kg IV for endotracheal intubation; Other Names: Atracurium besilate; Procedure: diclofenac sodium; 1 mg/kg for postoperative analgesia; Other Names: Voltaren; Procedure: desflurane; 1 MAC concentration (expired fraction of 6.0 vol%) for maintenance of anesthesia; Other Names: Suprane
Placebo Comparator: 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.	Procedure: Ondansetron; 0.15 mg/kg intravenous (IV) will be given as a pre-medication; Other Names: Zofran; Procedure: fentanyl; 1.5 μg/kg intraoperative; Other Names: Sublimaze,Actiq, Durogesic, Duragesic; Procedure: propofol; 10 mg every 5 seconds until the BIS level dropped below 60 for induction of anesthesia; Other Names: Diprivan; Procedure: Atracurium; 0.5 mg/kg IV for endotracheal intubation; Other Names: Atracurium besilate; Procedure: diclofenac sodium; 1 mg/kg for postoperative analgesia; Other Names: Voltaren; Procedure: desflurane; 1 MAC concentration (expired fraction of 6.0 vol%) for maintenance of anesthesia; Other Names: Suprane; Drug: Placebo; A maintenance dose of 20 mL with normal saline will be administered at a rate similar to that of dexmedetomidine; Other Names: placebo effect

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
desflurane consumption (ml)	Calculation of desflurane consumption during the intraoperative period	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Heart Rate (Beat/min)	Recording of the heart rate during the intraoperative period before induction, after induction, after intubation, and then at 5, 10, 15, 30, 45, and 60 minute after intubation and at extubation.	Intraoperative
Blood Pressure (mm Hg)	Recording of the heart rate during the intraoperative period before induction, after induction, after intubation, and then at 5, 10, 15, 30, 45, and 60 minute after intubation and at extubation.	Intraoperative
Fentanyl consumption (ug)	Total intraoperative fentanyl consumption	Intraoperative

Collaborators and Investigators

• Sponsor: Theodor Bilharz Research Institute
• Investigators: Study Director: Abla El Hadidy, PhD, Theodor Bilharz Research Institute

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: February 1, 2016
• Primary Completion (Actual): October 1, 2016
• Study Completion (Actual): October 1, 2016

Study Registration Dates

• First Submitted: January 6, 2016
• First Submitted That Met QC Criteria: January 7, 2016
• First Posted (Estimate): January 11, 2016

Study Record Updates

• Last Update Posted (Estimate): November 10, 2016
• Last Update Submitted That Met QC Criteria: November 9, 2016
• Last Verified: November 1, 2016

More Information

Terms related to this study

• Keywords: Dexmedetomidine; Desflurane; Bispectral Index BIS
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Antagonists; Cholinergic Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Antiemetics; Gastrointestinal Agents; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Dermatologic Agents; Analgesics, Opioid; Narcotics; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Serotonin Antagonists; Hypnotics and Sedatives; Adjuvants, Anesthesia; Anti-Anxiety Agents; Anesthetics, Inhalation; Neuromuscular Agents; Antipruritics; Nicotinic Antagonists; Neuromuscular Nondepolarizing Agents; Neuromuscular Blocking Agents; Fentanyl; Propofol; Dexmedetomidine; Desflurane; Diclofenac; Ondansetron; Atracurium
• Other Study ID Numbers: Anesthesia 110T

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No