Intravenous Sedation Versus General Anesthesia in Patients Undergoing Minor Gynecologic Surgery

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01890707
• Other study ID #: STU00062431
• Status: Terminated
• Phase: N/A
• Start date: October 19, 2012
• Est. completion date: April 17, 2014

Study information

• Verified date: December 2019
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 19
• Est. completion date: April 17, 2014
• Est. primary completion date: April 15, 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anesthesia
• Pain
• Surgery

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Prentice Womens' Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (12)

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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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

* Note: There are 12 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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