Intravenous Sedation Versus General Anesthesia in Patients Undergoing Minor Gynecologic Surgery

December 11, 2019 updated by: Shireen Ahmad, Northwestern University

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Once consent for the study has been obtained subjects will be randomly allocated into 2 groups, using a computer generated table of random numbers. Anesthetic management will be standardized (Appendix 1, 2). Group A (study group) will receive deep sedation . Group B (control group) will receive general anesthesia. Subjects will be instructed preoperatively, on the proper use of the verbal rating scale (VRS) for pain and nausea scores. All patients routinely have a blood count checked preoperatively and based on the results are either screened for cross matched for potential transfusion. All subjects will complete the POMS questionnaire preoperatively.

Gestational size will be determined by the surgeon preoperatively using the most recent ultrasound measurements.

Participants will undergo a standard pre-operative evaluation, laboratory testing and laminaria insertion one day prior to surgery in the Family Planning and Contraception Clinic. All subjects will receive a prescription for ibuprofen 600mg and hydrocodone/acetaminophen 5/325mg with standardized instructions to take the last oral dose no later than six hours before the operative time. The last dose medication and time of administration will be recorded.

Intraoperative management:

A standardized intraoperative anesthetic protocol will be utilized by the anesthesia personnel (Appendix #1, 2).Clinical management of excessive intraoperative bleeding will be at the discretion of the anesthesiologist.

Intraoperative red blood cell loss will be estimated based on hematacrit of the contents of suction canister. The surgical field will be draped carefully so that all blood lost will either be collected in the suction canister or the pocket of the vaginal drape, so that it can also be suction into the canister prior to obtaining the laboratory sample. Every attempt will be made by the surgeons to keep all unaccounted blood loss to gloves, instruments, drapes, surgery table and OR floor, to a minimum. The suction tubing will be rinsed with50 mls of saline at the end of the procedure.

All participants will receive a standard paracervical block of 20ml. of 1% lidocaine with 5 units of vasopressin. Further uterotonics or surgical intervention for excessive bleeding will be at the discretion of the surgeon and documented in study data sheets.

Postoperative management:

Immediately postoperatively the surgeon of record will be asked to rate the quality of the anesthesia provided to the patient. He / she will complete a Surgeon Satisfaction with Intraoperative Sedation survey. (Appendix # 3)

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. Subjects will receive oral analgesics unless they are unable to take oral analgesics, in which case IV hydromorphone will be administered.

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 ondansetron 4mg IV.

Postoperative blood loss will be measured by weighing the patient dressings with a precision computerized scale system prior to discarding them. Prior to the subjects discharge from the facility, a drop of venous blood will be obtained from the existing intravenous catheter, for measurement hemoglobin. Hemoglobin determination of less than 8 gms/dL, will be verified with the hospital laboratory. Management decisions will be made in conjunction with the surgeon, based on the subject's clinical status.

Recovery from anesthesia and return of psychomotor ability will be assessed using the Modified Post Anesthesia Discharge Scoring System (MPADSS, see Appendix #6). A score of > 9 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.

Times from end of surgery to oral intake and readiness for discharge, and all adverse events and medications administered will be recorded. Subjects will be contacted by telephone 24 hours after surgery to obtain post-discharge data, including a QoR-40 assessment and a Pittsburgh Sleep Quality Index survey (PSQI).

Discharge analgesia and antiemetic medications will be standardized.

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Prentice Womens' Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Deep Sedation
Deep sedation
Procedure: Deep Sedation
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.
Other: General Anesthesia
Administration of general anesthesia. Propofol given IV, succinylcholine and rocuronium given IV and Sevoflurane via the endotracheal tube.
Procedure: General Anesthesia
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Recovery - 40 Scores
Time Frame: 24 hours

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Shireen Ahmad, M.D., Northwestern University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 19, 2012

Primary Completion (Actual)

April 15, 2014

Study Completion (Actual)

April 17, 2014

Study Registration Dates

First Submitted

June 1, 2012

First Submitted That Met QC Criteria

July 1, 2013

First Posted (Estimate)

July 2, 2013

Study Record Updates

Last Update Posted (Actual)

January 2, 2020

Last Update Submitted That Met QC Criteria

December 11, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STU00062431

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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