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

NCT01337739 | Terminated Results

• 1 other identifier: STU00027663
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Pain

Keywords

Hysteroscopic Surgery; Dexmedetomidine; Sedation; Opioids

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Time to Discharge

  24 Hours

Study Arms (2)

Placebo Comparator

PLACEBO COMPARATOR

Continuous infusion of placebo during operative procedure

Drug: Placebo Comparator

Active Comparator

ACTIVE COMPARATOR

Administration of Dexmedetomidine

Drug: Active Comparator

Interventions

Placebo Comparator DRUG

Placebo administration (.9 normal saline sterile)

Placebo Comparator

Active Comparator DRUG

Administration of Dexmedetomidine

Active Comparator

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• ASA I-II
• Age: 18-64 years
• Female
• Surgery: Gynecologic hysteroscopy
• Language: English speaking
• Consent: Obtained

You may not qualify if:

• 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 α2-agonists
• Patients with OSA or BMI greater than 30
• Allergy to study drug or anesthetic medications utilized in the protocol

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (2)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Prentice Womens Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (12)

• 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. doi: 10.1097/00000542-200602000-00005.

  PMID: 16436839 BACKGROUND

• 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.

  PMID: 19576524 BACKGROUND

• Bhana N, Goa KL, McClellan KJ. Dexmedetomidine. Drugs. 2000 Feb;59(2):263-8; discussion 269-70. doi: 10.2165/00003495-200059020-00012.

  PMID: 10730549 BACKGROUND

• 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.

  PMID: 18165564 BACKGROUND

• Taghinia AH, Shapiro FE, Slavin SA. Dexmedetomidine in aesthetic facial surgery: improving anesthetic safety and efficacy. Plast Reconstr Surg. 2008 Jan;121(1):269-276. doi: 10.1097/01.prs.0000293867.05857.90.

  PMID: 18176230 BACKGROUND

• 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. doi: 10.1213/01.ANE.0000219592.82598.AA.

  PMID: 16790627 BACKGROUND

• 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. doi: 10.1016/j.jclinane.2006.07.005.

  PMID: 17379129 BACKGROUND

• 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. doi: 10.1213/01.ane.0000197777.62397.d5.

  PMID: 16492813 BACKGROUND

• 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. doi: 10.1097/00000539-200208000-00042.

  PMID: 12145072 BACKGROUND

• 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.

  PMID: 18499604 BACKGROUND

• 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.

  PMID: 2286697 BACKGROUND

• Chung F. Discharge criteria--a new trend. Can J Anaesth. 1995 Nov;42(11):1056-8. doi: 10.1007/BF03011083.

  PMID: 8590498 BACKGROUND

MeSH Terms

Conditions

Pain

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination of the study due to increased discharge time from the post anesthesia care unit with subjects receiving dexmedetomidine. The delay was consistent among the group.

Results Point of Contact

• Title: Paul Fitzgerald
• Organization: Northwestern University

p-fitzgerald2@northwestern.edu

312-472-3539

Study Officials

• Shireen Ahmad, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2010
• First Posted: April 19, 2011
• Study Start: October 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: April 1, 2012
• Last Updated: July 12, 2013
• Results First Posted: July 12, 2013

Record last verified: 2013-05

Locations

US (2)