Medical Student Research Fellowship for Summer 2006

Mentor: Babatunde Ogunnaike, MD
Department: Anesthesiology & Pain Management
Room number: F2.208
Mail Code: 9068
Phone number: 214-648-6424
E-mail: dolly.tutton@utsouthwestern.edu
Project title: A randomized, double-blind, placebo-controlled, escalating dose-response trial of inravenous adenosine (Adenodesic®) for perioperative analgesia in females undergoing total abdominal hysterectomy or myomectomy

Human subjects IRB approved project number (where applicable): 082005-037

Animal subjects IRB approved project number (where applicable): N/A

Project Type (patient-based research, animal-based research, or basic research; this characterization is only to permit a general classification for grouping similar types of projects): Patient-based research

Brief Description of Project:

The purpose of this research study is to investigate a new use for a drug called adenosine (Adenogesic ) to see if it decreases the amount of opioid pain medications needed during and after surgery, as well as the amount of anesthesia drugs needed during surgery. The study will also determine what dose of adenosine is optimal without producing side effects when it is given during surgery.

Approximately 160 subjects will be randomized to treatment arms with 1 of 4 active doses or a matching placebo dose in an escalating dose cohort approach. Within each dose cohort an estimated 30 subjects will be randomized to adenosine and 10 to placebo. During the treatment period, the subject will undergo surgery utilizing a standardized anesthesia regimen. Hemodynamic parameters and Bispectral Index (BIS) monitoring will be assessed continuously throughout the procedure. During the postoperative period, the following procedures/assessments will be performed: verbal rating scale (VRS) pain scores, vital signs, and modified Observer Assessment of Alertness/Sedation (OAA/S) scale assessments will be performed every 15 minutes in the postoperative care unit (PACU), every hour for 4 hours, then every 4 hours for 48 hours or until discharge, whichever occurs first; an assessment of the subject's recovery utilizing the Aldrete score will be performed every 15 minutes while in the PACU; 12-lead ECG will be obtained prior to discharge from PACU; adverse event (AE) and serious adverse event (SAE) assessments; opioid-related Symptom Distress Scale (SDS) assessments and patient satisfaction with pain control at 24 hours and 48 hours; clinical lab assessments(at approximately 24 hours after surgery, approximately 2 tablespoons (5-10 cc) of blood will be drawn) 24 hours post-op or discharge, whichever occurs first. From 48 hours through postoperative day 7, need for pain and nausea medications will be collected daily via diary card. The subject will be contacted via telephone on day 4 and day 7.

Previous Research Activities or Publications with Medical Students:

Song D, Singh H, White PF, Gadhiali M, Griffin, JD, Klein KW: Optimal dose of nicardipine for maintenance of hemodynamic stability after tracheal intubation and skin incision. Anesth Analg 1997; 85: 1247-51.

Song D, Heise DA, White PF: Facial electromyography correlates with the level of sedation and pain in outpatients undergoing lithotripsy. Anesthesiology 1998; 89: A928.

Fredman B, d'Etienne BA, Taylor E, Smith I, White PF: Use of low-dose propofol vs methohexital for electroconvulsive therapy. Anesth Analg 1994; 78: S120.

Zarate E, Watcha MF, White PF, Klein KW, Sá Rêgo M, Stewart DG: A comparison of the costs and efficacy of ondansetron versus dolasetron for antiemetic prophylaxis. Anesth Analg 2000 90: 1352-8.

Shao X, Li H, White PF, Klein KW, Kulstad C, Owens A: Bisulfite-containing propofol: is it a cost-effective alternative to Diprivan for induction of anesthesia?. Anesth Analg 2000; 91: 871-5.

Coloma M, Markowitz SD, White PF, Whitten CW, Berrisford SB: Effect of dexamethasone on the prophylactic antiemetic activity of dolasetron. Anesthesiology 2001; 95: A-40.

Kadar AG, Ing CH, White PF, Wakefield CA, Kramer BA, Clark K: Anesthesia for electroconvulsive therapy in obese patients. Anesth Analg 2002; 94: 360-1.

Issioui T, Klein KW, White PF, Watcha MF, Skrivanek GD, Jones SB, Hu J, Marple BF, Ing C: Cost-efficacy of rofecoxib versus acetaminophen for preventing pain after ambulatory surgery. Anesthesiology 2002; 97: 931-7.

Coloma M, White PF, Markowitz SD, Whitten CW, Macaluso A, Berrisford S, Thornton K: Dexamethasone in combination with dolasetron for prophylaxis in the ambulatory setting: effect on outcome after laparoscopic cholecystectomy. Anesthesiology 2002; 97: 1387-92.

White PF, Issioui T, Hu J, Jones SB, Coleman JE, Waddle JP, Markowitz SD, Coloma M, Macalusco AD, Ing CH: Comparative efficacy of acustimulation (ReliefBand ) and ondansetron (Zofran ) in combination with droperidol for preventing nausea and vomiting. Anesthesiology 2002; 97: 1075-81.

Coloma M, White PF, Ogunnaike BO, Markowitz SD, Brown PM, Lee AQ, Berrisford SB, Wakefield CA, Jones SB, Jones DB: Comparison of acustimulation and ondansetron for the treatment of established postoperative nausea and vomiting. Anesthesiology 2002; 97: 1387-92.

Issioui S, Jones B, White PF, Hu J, Rawal S, Ing C: Comparative efficacy of ondansetron and the Reliefband for antiemetic prophylaxis in outpatients undergoing plastic surgery. Anesth Analg 2002; 94: S3.
Issioui T, Klein KW, White PF, Rawal S, Skrivanek GD, Ing C: Comparison of ibuprofen, celecoxib and rofecoxib as premedication prior to outpatient orthopedic surgery. Anesth Analg 2002; 94: S4.
Coloma M, White PF, Markowitz SD, Jones SB, Wakefield CA, Berrisford SB: Comparison of the acustimulation ReliefBand device to ondansetron for treatment of PONV after ambulatory surgery. Anesth Analg 2002; 94: S12.

Coloma M, Ogunnaike BO, White PF, Lee AQ, Brown PM, Wakefield CA: Comparative analgesic efficacy of ibuprofen, ketorolac and rofecoxib in preventing pain after ambulatory surgery. SAMBA annual meeting May, 2002, poster 10.

White PF, Rawal S, Latham P, Markowitz S, Issioui T, Chi L, Dellaria S, Shi C, Morse L, Ing C: Use of a continuous local anesthetic infusion for pain management after median sternotomy. Anesthesiology 2003; 99: 918-23.

White PF, Issioui T, Skrivanek GD, Early JS, Wakefield C: The use of a continuous popliteal sciatic nerve block after surgery involving the foot and ankle: does it improve quality of recovery? Anesth Analg 2003; 97: 1303-9.

Recart A, White PF, Wang A, Gasanova I, Byerly S, Jones SB: Effect of evoked potential index monitoring on anesthetic drug requirements and recovery profile after laparoscopic surgery: A clinical utility study. Anesthesiology 2003; 99: 813-8.

Recart A, Gasanova I, White PF, Thomas T, Ogunnaike B, Hamza M, Wang A: Effect of cerebral monitoring on recovery after general anesthesia: comparison of AEP vs BIS devices vs standard practice. Anesth Analg 2003; 97: 1667-74.

Recart A, Duchene D, White PF, Thomas T, Johnson DB: Efficacy and safety of fast-track recovery strategy for patients undergoing laparoscopic nephrectomy. J Endourol 2005; 19: 1165-9.

White PF, Song D, Abrao J, Klein KW, Navarette B: Effect of low-dose droperidol on the QT interval during general anesthesia: a placebo-controlled study. Anesthesiology 2005; 102:1101-5.

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