Use of Dexmedetomidine for Deep Sedation in Patients Undergoing Outpatient Hysteroscopic Surgery

Pain Clinical Trial

Official title:

Use of Dexmedetomidine for Deep Sedation in Patients Undergoing Outpatient Hysteroscopic Surgery

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01337739
• Other study ID #: STU00027663
• Status: Terminated
• Phase: N/A
• First received: April 19, 2010
• Last updated: May 23, 2013
• Start date: October 2010
• Est. completion date: April 2012

Study information

• Verified date: May 2013
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

Patients undergoing deep sedation for outpatient procedures typically receive a combination of benzodiazepines, propofol, and opioids. Side effects of such anesthetics include respiratory depression, nausea and vomiting, and urinary retention, with resultant extended hospital stays and unanticipated admission. The use of dexmedetomidine for deep sedation may increase patient safety by maintaining respiratory drive, while providing sedation, hypnosis, and analgesia. Furthermore, patients may experience decreased pain, nausea, and time to discharge in the PACU, especially if dexmedetomidine decreases the requirement of other drugs such as opioids.

The hypothesis of this study is administration of dexmedetomidine during deep sedation for ambulatory hysteroscopic surgery will result in a 50% reduction of intraoperative opioid compared to sedation with propofol.

Description:

Patients will be recruited up to 21 days prior to the day of surgery. Preoperatively: A full preoperative assessment will be completed. Preoperatively, patients will be instructed on the proper use of the verbal rating scale (VRS) for pain and nausea scores. Patients will be randomized by a computer-generated scheme to receive prepared infusions containing either dexmedetomidine (4grams per milliliter or propofol (10 milligrams per milliliter) intraoperatively. The study drug infusions will be prepared by study personnel who are not involved in the assessments. Patients, medical personnel other than the anesthesiologist, and outcome assessors will be blinded to treatment allocation. Only the anesthesiologist administering the treatment infusion and medications intraoperatively will be aware of group allocation.

Intraoperatively: A standardized intraoperative anesthetic plan will be utilized by the anesthesia personnel.All patients will receive premedication with midazolam 2 milligrams intravenous bolus and ketorolac 30 milligrams via the intravenous catheter.

Intraoperative monitoring will include standard monitoring which includes noninvasive blood pressure, electrocardiography, pulse oximetry, and capnography. In addition transcutaneous CO2 will be monitored using the Tosca monitor.(Radiometer, Basel, Austria).

The study drug infusion will be started as either dexmedetomidine (1gram per kilogram over 10 min as a loading dose, followed by a maintenance infusion 0.2 to 1.5 grams per kilogram or propofol (started at 75gram per kilogram per minute and ranging from 12.5 to 125 gram per kilogram per minute titrated to maintain the Observer's Assessment of Alertness/Sedation Scale (OAA/SS) between 0-1. Intraoperative fluids will be restricted to 500 milliliter + 100mililiterml of Lactated Ringer's solution. At the onset of the procedure, the anesthesiologist will administer 0.7gram/kilogram bolus of fentanyl intravenous, followed by additional 25-50gram boluses for any patient movement to surgical stimulus. All patients will receive ondansetron 4 milligram IV 15-20 minutes prior to the end of surgery. Patients will receive glycopyrrolate 0.2 mg IV if HR decreases below 50 bpm.

Postoperatively:

In the recovery room, VRS for pain will be assessed upon admission and at 30 minute intervals thereafter. Analgesics will be administered according to the severity of the pain and degree of alertness.Vomiting and retching episodes.will be assessed at 30 minute intervals using a VRS, and patients with scores greater than 4 or those who request antiemetic treatment will be treated with metoclopramide 10 mg IV.

Recovery from anesthesia and return of psychomotor ability will be assessed using the Modified Post Anesthesia Discharge Scoring System (MPADSS). A score of 8 or greater will indicate discharge readiness. Discharge readiness requires that a patient be awake and alert with stable vital signs, able to ambulate without assistance, and free of side effects. 24 hours after discharge.

Times from end of surgery to oral intake and readiness for discharge, , and all adverse events and medications administered will be recorded. These data will be recorded by research staff blinded to the study group assignments. Subjects will be contacted by telephone 24 hours after surgery to obtain post-discharge data, including a repeat QoR-40 assessment.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

Inclusion Criteria:

• ASA I-II

• Age: 18-64 years

• Female

• Surgery: Gynecologic hysteroscopy

• Language: English speaking

• Consent: Obtained

Exclusion Criteria:

• Pregnant or breast feeding

• Significant arrhythmia or high degree atrioventricular nodal block

• Significant hepatic or renal dysfunction

• Chronic use or addiction to opiates or sedatives

• History of heavy alcohol usage (>4 drinks/day)

• Psychiatric or emotional disorder

• Chronic use of a2-agonists

• Patients with OSA or BMI greater than 30

• Allergy to study drug or anesthetic medications utilized in the protocol

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Placebo Comparator
Placebo administration (.9 normal saline sterile)
• Active Comparator
Administration of Dexmedetomidine

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois
United States	Prentice Womens Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (12)

Arain SR, Ebert TJ. The efficacy, side effects, and recovery characteristics of dexmedetomidine versus propofol when used for intraoperative sedation. Anesth Analg. 2002 Aug;95(2):461-6, table of contents. — View Citation

Bergese SD, Khabiri B, Roberts WD, Howie MB, McSweeney TD, Gerhardt MA. Dexmedetomidine for conscious sedation in difficult awake fiberoptic intubation cases. J Clin Anesth. 2007 Mar;19(2):141-4. Erratum in: J Clin Anesth. 2007 Jun;19(4):323. — View Citation

Bhana N, Goa KL, McClellan KJ. Dexmedetomidine. Drugs. 2000 Feb;59(2):263-8; discussion 269-70. — View Citation

Bhananker SM, Posner KL, Cheney FW, Caplan RA, Lee LA, Domino KB. Injury and liability associated with monitored anesthesia care: a closed claims analysis. Anesthesiology. 2006 Feb;104(2):228-34. — View Citation

Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, Schwam EM, Siegel JL. Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol. 1990 Aug;10(4):244-51. — View Citation

Chung F. Discharge criteria--a new trend. Can J Anaesth. 1995 Nov;42(11):1056-8. — View Citation

Kaygusuz K, Gokce G, Gursoy S, Ayan S, Mimaroglu C, Gultekin Y. A comparison of sedation with dexmedetomidine or propofol during shockwave lithotripsy: a randomized controlled trial. Anesth Analg. 2008 Jan;106(1):114-9, table of contents. doi: 10.1213/01.ane.0000296453.75494.64. — View Citation

Koroglu A, Teksan H, Sagir O, Yucel A, Toprak HI, Ersoy OM. A comparison of the sedative, hemodynamic, and respiratory effects of dexmedetomidine and propofol in children undergoing magnetic resonance imaging. Anesth Analg. 2006 Jul;103(1):63-7, table of contents. — View Citation

McCutcheon CA, Orme RM, Scott DA, Davies MJ, McGlade DP. A comparison of dexmedetomidine versus conventional therapy for sedation and hemodynamic control during carotid endarterectomy performed under regional anesthesia. Anesth Analg. 2006 Mar;102(3):668-75. — View Citation

Panzer O, Moitra V, Sladen RN. Pharmacology of sedative-analgesic agents: dexmedetomidine, remifentanil, ketamine, volatile anesthetics, and the role of peripheral mu antagonists. Crit Care Clin. 2009 Jul;25(3):451-69, vii. doi: 10.1016/j.ccc.2009.04.004. — View Citation

Taghinia AH, Shapiro FE, Slavin SA. Dexmedetomidine in aesthetic facial surgery: improving anesthetic safety and efficacy. Plast Reconstr Surg. 2008 Jan;121(1):269-76. doi: 10.1097/01.prs.0000293867.05857.90. — View Citation

Tufanogullari B, White PF, Peixoto MP, Kianpour D, Lacour T, Griffin J, Skrivanek G, Macaluso A, Shah M, Provost DA. Dexmedetomidine infusion during laparoscopic bariatric surgery: the effect on recovery outcome variables. Anesth Analg. 2008 Jun;106(6):1741-8. doi: 10.1213/ane.0b013e318172c47c. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Primary Outcome Will be the Difference in Intraoperative Opioid (Fentanyl) Administration Between Patients Receiving Dexmedetomidine and Those Receiving Propofol.	The primary outcome will be the difference in intraoperative opioid (fentanyl) administration between patients receiving dexmedetomidine and those receiving propofol. As described by mean and standard deviation.	Interoperative period	No
Secondary	Time to Discharge	Time to discharge from the Post Anesthesia Care Unit or home or to hospital room.	24 Hours	No