Clinical trial NCT01890707: Intravenous Sedation Versus General Anesthesia in Patients Undergoing Minor Gynecologic Surgery
Official title: A Comparison of the Effect of Intravenous Sedation Versus General Anesthesia in Patients Undergoing Minor Gynecologic Surgery
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Surgery
Anesthesia
Pain
Keywords: Gynecology
Pain
Anesthesia
Quality of Recovery 40
Lead sponsor: Northwestern University
Sponsor class: OTHER
First posted: 2013-07-02
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Quality of Recovery - 40 Scores
timeFrame: 24 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Prentice Womens' Hospital
state: Illinois
Study officials:
affiliation: Northwestern University
name: Shireen Ahmad, M.D.
role: PRINCIPAL_INVESTIGATOR
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