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Intravenous Sedation Versus General Anesthesia in Patients Undergoing Minor Gynecologic Surgery

Information source: Northwestern University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Surgery; Anesthesia; Pain

Intervention: Endotracheal intubation (Procedure); Deep Sedation (Procedure); Fentanyl (Sublimaze TM) (Drug); fluoromethyl hexafluoroisopropyl ether (Sevoflurane TM) (Drug); Succinylcholine (Suxamethonium chloride) (Drug); Rocuronium (Zemuron TM) (Drug); Propofol (Diprivan TM) (Drug); Ketamine (Drug)

Phase: N/A

Status: Recruiting

Sponsored by: Northwestern University

Official(s) and/or principal investigator(s):
Shireen Ahmad, M.D., Principal Investigator, Affiliation: Northwestern University

Overall contact:
Shireen Ahmad, M.D., Phone: 312-472-3585, Email: sah704@northwewstern.edu


The use of deep sedation may improve the quality of recovery of patients undergoing minor gynecologic procedures. These patients may also have shorter hospital stays and potentially lower healthcare costs. Additionally, the use of deep sedation for second trimester pregnancy termination may be associated with less bleeding, a smaller decrease in perioperative hemoglobin and better quality of recovery.

Clinical Details

Official title: A Comparison of the Effect of Intravenous Sedation Versus General Anesthesia in Patients Undergoing Minor Gynecologic Surgery

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Quality of Recovery - 40 scores

Secondary outcome:

Incidence and severity of postoperative pain

Analgesic and antiemetic consumption


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.


Inclusion Criteria:

- Female patients undergoing second trimester abortions:

- Pregnancy: 12-24 weeks gestational size

- ASA PS I and II

- No history of diabetes mellitus, GERD or sleep apnea

- Age: > 18 years of age

- Fluent in English

Exclusion Criteria:

- ASA PSIII, Emergency surgery

- Pregnancy: > 24 weeks gestational size

- Age: < 18 years of age

- Diabetes mellitus

- Gastroesophageal reflux disease

- Hiatal hernia

- Obstructive sleep apnea

- Coagulopathy

- Chronic pain syndromes

- Chronic opioid dependency

- Alcohol or illicit drug abuse

- BMI: > 35Kg/m2

- Allergy to study protocol drugs

Drop out criteria:

- Subjects withdrawal of consent.

- Subjects who experience massive bleeding intraoperatively, will be excluded from the

final data analysis

Locations and Contacts

Shireen Ahmad, M.D., Phone: 312-472-3585, Email: sah704@northwewstern.edu

Prentice Womens' Hospital, Chicago, Illinois 60611, United States; Recruiting
Shireen Ahmad, M.D., Phone: 312-472-3585, Email: sah704@northwestern.edu
Shireen Ahmad, M.D., Principal Investigator
Additional Information

Related publications:

Sá Rêgo MM, White PF. What is new in monitored anesthesia care? Curr Opin Anaesthesiol. 1998 Dec;11(6):601-6.

Sá Rêgo MM, Watcha MF, White PF. The changing role of monitored anesthesia care in the ambulatory setting. Anesth Analg. 1997 Nov;85(5):1020-36. Review.

Song D, Greilich NB, White PF, Watcha MF, Tongier WK. Recovery profiles and costs of anesthesia for outpatient unilateral inguinal herniorrhaphy. Anesth Analg. 2000 Oct;91(4):876-81.

Snyder SK, Roberson CR, Cummings CC, Rajab MH. Local Anesthesia With Monitored Anesthesia Care vs General Anesthesia in Thyroidectomy: A Randomized Study. Arch Surg. 2006 Feb;141(2):167-73.

Scarborough DA, Herron JB, Khan A, Bisaccia E. Experience with more than 5,000 cases in which monitored anesthesia care was used for liposuction surgery. Aesthetic Plast Surg. 2003 Nov-Dec;27(6):474-80. Epub 2004 Mar 4. Review.

Eldor L, Weissman A, Fodor L, Carmi N, Ullmann Y. Breast augmentation under general anesthesia versus monitored anesthesia care: a retrospective comparative study. Ann Plast Surg. 2008 Sep;61(3):243-6. doi: 10.1097/SAP.0b013e31815bfe98.

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Warner MA, Shields SE, Chute CG. Major morbidity and mortality within 1 month of ambulatory surgery and anesthesia. JAMA. 1993 Sep 22-29;270(12):1437-41.

Aldrete JA, Kroulik D. A postanesthetic recovery score. Anesth Analg. 1970 Nov-Dec;49(6):924-34.

White PF. Criteria for fast-tracking outpatients after ambulatory surgery. J Clin Anesth. 1999 Feb;11(1):78-9.

Chung F, Chan VW, Ong D. A post-anesthetic discharge scoring system for home readiness after ambulatory surgery. J Clin Anesth. 1995 Sep;7(6):500-6.

Wong J, Tong D, De Silva Y, Abrishami A, Chung F. Development of the functional recovery index for ambulatory surgery and anesthesia. Anesthesiology. 2009 Mar;110(3):596-602. doi: 10.1097/ALN.0b013e318197a16d.

Starting date: June 2012
Last updated: February 2, 2015

Page last updated: August 23, 2015

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