NCT01890707

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for not_applicable surgery

Timeline
Completed

Started Oct 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 1, 2012

Completed
5 months until next milestone

Study Start

First participant enrolled

October 19, 2012

Completed
9 months until next milestone

First Posted

Study publicly available on registry

July 2, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2014

Completed
2 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2014

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

January 2, 2020

Completed
Last Updated

January 2, 2020

Status Verified

December 1, 2019

Enrollment Period

1.5 years

First QC Date

June 1, 2012

Results QC Date

September 12, 2017

Last Update Submit

December 11, 2019

Conditions

SurgeryAnesthesiaPain

Keywords

GynecologyPainAnesthesiaQuality of Recovery 40

Outcome Measures

Primary Outcomes (1)

  • Quality of Recovery - 40 Scores

    The patients self reported quality of recovery - 40 scores as completed 24 hours after the surgical procedure. 40 questions regarding the recovery of patients on a 1 poor-5 excellent scale. Total score on scale 40 (poor recovery)-200 (excellent recovery)

    24 hours

Study Arms (2)

Deep Sedation

ACTIVE COMPARATOR

Deep sedation

Procedure: Deep Sedation

General Anesthesia

OTHER

Administration of general anesthesia. Propofol given IV, succinylcholine and rocuronium given IV and Sevoflurane via the endotracheal tube.

Procedure: General Anesthesia

Interventions

General AnesthesiaPROCEDURE

Administer: Fentanyl:1mcg/kg prior to induction, additional doses to maintain blood pressure and heart rate within 20% of preoperative values, Propofol:2mg/kg,succinylcholine, 0.5mg/kg,to be followed with Rocuronium if necessary,bolus: 0.4mg/kg, Sevoflurane and oxygen to be titrated to maintain BIS value of 40-60.

General Anesthesia
Deep SedationPROCEDURE

IV administration of Propofol,initial rate 100ug/kg/min, titrated to maintain BIS 65-75,Fentanyl,Ketamine,1mcg/kg,0.5mg/kg,additional 10mg increments for analgesia/movement.

Deep Sedation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Prentice Womens' Hospital

Chicago, Illinois, 60611, United States

Location

Related Publications (12)

  • Sa Rego MM, White PF. What is new in monitored anesthesia care? Curr Opin Anaesthesiol. 1998 Dec;11(6):601-6. doi: 10.1097/00001503-199811000-00003.

    PMID: 17013278BACKGROUND

  • Sa Rego MM, Watcha MF, White PF. The changing role of monitored anesthesia care in the ambulatory setting. Anesth Analg. 1997 Nov;85(5):1020-36. doi: 10.1097/00000539-199711000-00012. No abstract available.

    PMID: 9356094BACKGROUND

  • 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. doi: 10.1097/00000539-200010000-00020.

    PMID: 11004041BACKGROUND

  • 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. doi: 10.1001/archsurg.141.2.167.

    PMID: 16490894BACKGROUND

  • 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. doi: 10.1007/s00266-003-3043-9. Epub 2004 Mar 4.

    PMID: 14994165BACKGROUND

  • 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.

    PMID: 18724120BACKGROUND

  • EDWARDS G, MORTON HJ, PASK EA, WYLIE WD. Deaths associated with anaesthesia; a report on 1,000 cases. Anaesthesia. 1956 Jul;11(3):194-220. doi: 10.1111/j.1365-2044.1956.tb07975.x. No abstract available.

    PMID: 13340197BACKGROUND

  • 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. doi: 10.1001/jama.270.12.1437.

    PMID: 8371443BACKGROUND

  • Aldrete JA, Kroulik D. A postanesthetic recovery score. Anesth Analg. 1970 Nov-Dec;49(6):924-34. No abstract available.

    PMID: 5534693BACKGROUND

  • White PF. Criteria for fast-tracking outpatients after ambulatory surgery. J Clin Anesth. 1999 Feb;11(1):78-9. doi: 10.1016/s0952-8180(98)00119-6. No abstract available.

    PMID: 10396724BACKGROUND

  • 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. doi: 10.1016/0952-8180(95)00130-a.

    PMID: 8534468BACKGROUND

  • 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.

    PMID: 19212260BACKGROUND

MeSH Terms

Conditions

Pain

Interventions

Anesthesia, GeneralDeep Sedation

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

AnesthesiaAnesthesia and Analgesia

Results Point of Contact

Title
Shireen Ahmad MD
Organization
Northwestern University
sahmad@northwestern.edu
312-472-3585

Study Officials

  • Shireen Ahmad, M.D.

    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, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 1, 2012

First Posted

July 2, 2013

Study Start

October 19, 2012

Primary Completion

April 15, 2014

Study Completion

April 17, 2014

Last Updated

January 2, 2020

Results First Posted

January 2, 2020

Record last verified: 2019-12

Data Sharing

IPD Sharing
Will not share

Locations

US(1)