Intravenous Sedation Versus General Anesthesia in Patients Undergoing Minor Gynecologic Surgery

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.

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.

Criteria:

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

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

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