Health Condition 1: O- Medical and Surgical
Conditions
Interventions
Intervention1: phenylephrine: In the phenylepinephrine group, dilute phenylepinephrine {0.5 mg of epinephrine) in 50 ml of saline solution will be used, taking care to use no more than 200 ml of solut
Sponsors
All india institute of medical sciences Patna
Eligibility
Inclusion criteria
Inclusion criteria: 1. Age between 15-49 years. 2. BMI between 18-29.9. 3. 1-5 symptomatic intramural myomas 4. Presenting with abnormal uterine bleeding, pelvic pressure or pain, infertility or recurrent miscarriage and are candidates for abdominal myomectomy. 5. Largest uterine fibroid size of 6. not pregnant at the time of presentation (i.e. negative urine pregnancy test or last menstrual period within the last 4 weeks); 7. appropriate medical status for laparoscopic surgery (American Society of Anesthesiologists Physical Status Classification 1 or 2).
Exclusion criteria
Exclusion criteria: 1. History of previous abdominal or pelvic surgery except Cesarian section. 2. History of pelvic or ovarian endometriosis or abdominal tuberculosis. 3. Patient with subserous or submucosal fibroid or adenomyoma. 4. Patients who are not candidate for laparoscopic myomectomy. 5. any pelvic abnormalities requiring concomitant surgery 6. myoma with a maximal diameter of 10 cm based on pre-operative ultrasound 7. Allergy to phenylephrine and vasopressin 8. Hypertension, Diabetes Mellitus, Cardiac and pulmonary diseases. (ASA >2) 9. Obesity BMI > 30 kg/m². 10. Anemia Hb 11. Bleeding disorder or use of anticoagulation. 12. Preoperative use of hormonal therapy as GnRH analogues or oral contraceptive pills or mifepristone or ulipristal acetate within 3 months preceding surgery. 13. more than five myomas 14. conversion to open surgery 15. need for adhesiolysis 16. Pregnancy. 17. Postmenopausal. 18. Not giving written informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Intraoperative blood loss estimated by calculating the sum of canisters containing irrigation fluids and suctioned (ml)blood minus used irrigation solutionTimepoint: baseline, and after completion of surgery, that is skin closure | — |
Secondary
| Measure | Time frame |
|---|---|
| Blanching timeTimepoint: from injection of drug till blanching of myoma; Time of ambulationTimepoint: within 12 hours postoperative;1. Preoperative & postoperative haemoglobin & haematocrit values-Timepoint: baseline preoperatively, & 24 hours post-operatively;Anaesthesia timeTimepoint: from induction of patient till reversal;Mean drug concentration required for blanchingTimepoint: total drug required for myoma to blanch;Operation time -Timepoint: measured from incision of first myoma to serosal closure of last myoma wound in minutes;Perioperative blood pressure and HR -Timepoint: up to first four hours postoperative.;Post-operative hospital stayTimepoint: within 3 days postoperative ;Post-operative pain scoreTimepoint: using VAS from 1 to 10;Rate of complications and adverse effects to the drug- conversion to open surgery, intra-operative and post-operative complications, bradycardia, arrhythmias between the two groups.Timepoint: during surgery;Subjective surgical difficulty using 5-point Likert scaleTimepoint: likert score 1-5 | — |
Countries
India
Contacts
Public ContactDR MUKTA AGARWAL
All india institute of medical sciences, Patna
Outcome results
None listed