Uterine Fibroid is the most prevalent type of benign tumor in the female reproductive system with the prevalence of 24-40% among adult females. About 10% of the myomas are submucosal. Myoma is mostly asymptomatic. Size and location are the main factors that determine if a myoma leads to symptoms. One of the surgical management of fibroid is myomectomy. Myomectomy is associated with intraoperative complications such as excessive bleeding because of its rich blood supply. Therefore proper haemostasis and layered closure of uterus following myomectomy are very important  to minimize complications. Bleeding can be prevented if dissection done through the avascular cleft or decreased with mechanical or pharmacological methods. One of the commonly used pharmacologic method is use of vasopressin.In this background we decided to do an observational study on hemodynamic changes with intramyometrial vasopressin in patients undergoing elective gynaecological surgeries (myomectomy, hysterectomy) for fibroid uterus.

Study will be conducted on 125 women with symptomatic fibroids belongs to American Society of Anaesthesiologists Physical Status I & II whom are posted for elective laparoscopic or open myomectomy or  hysterectomy. Patients will be approached by primary investigator on the day prior to surgery after discussing with the surgical team. Informed consent will be taken from the patient. On the day of surgery baseline vital parameters will be recorded. The induction of anaesthesia will be done for all patients by preoxygenation with 100% oxygen, intravenous Fentanyl (1-2mcg/kg), propofol (1-2mg/kg), Atracurium (0.5mg/kg). After tracheal intubation anaesthesia will be maintained with oxygen: air (50:50%) and Isoflurane (2-3%). An additional dose of intravenous Atracurium (0.08-0.1mg/kg) will be given guided by the peripheral nerve stimulator to provide a train-of-four count zero. The ventilation will be adjusted to maintain EtCo2 30-35 mmHg. Isoflurane concentration will be adjusted to maintain the mean arterial blood pressure and heart rate within 20% of the pre-induction values. Intraoperative tachycardia (heart rate >100bpm) and hypertension (mean arterial blood pressure >20% above baseline) will be managed by increasing the concentration of Isoflurane by increments of 1.0% and bolus doses of Fentanyl (0.05-1mcg/kg). Intraoperative hypotension (mean arterial blood pressure <20% below baseline) will be managed by bolus doses of Ephedrine and fluid administration. Bradycardia (heart rate <60bpm) will be managed by a bolus dose of Atropine (0.02mg/kg). At the end of the surgery the Isoflurane will be discontinued and controlled ventilation with 100% oxygen will be maintained until the end tidal Isoflurane concentration becomes <0.1%. Residual neuromuscular blockade will be reversed with a combination of Neostigmine (0.05mg/kg) and Glycopyrrolate (0.01mg/kg) intravenously and then the patient will be extubated OR If regional anaesthesia is planned Spinal / Combined spinal Epidural anaesthesia will be given by the anaesthetist posted in the theatre.

                    The parameters - heart rate, systolic, diastolic and mean arterial blood pressure, ECG monitoring, arterial oxygen saturation(SPO2), end tidal carbon dioxide(EtCO2) will be recorded at serial intervals. These parameters will be recorded by concerned anesthetist posted in the list on the day of surgery.

1. VITAL SIGNS

               T0    :   preoperative value                                                                                                  

               T1    :   5 minutes after induction

             T2    :    just before intramyometrial vasopressin administration

             T3    :   1minute after vasopressin administration

              T4    :   2 minutes after vasopressin administration

             T5    :   3 minutes after vasopressin administration

             T6    :   4 minutes after vasopressin administration

             T7    :   5 minutes after vasopressin administration

               T8    :  10 minutes after vasopressin administration

               T9    :  15 minutes after vasopressin administration

               T10  :  20 minutes after vasopressin administration

               T11  :  30 minutes after vasopressin administration

               T12  :  45 minutes after vasopressin administration

               T13  :  60 minutes after vasopressin administration

             T14  :   after 60 minutes in the postoperative care unit

2. Episodes of hypotension/hypertension /treatment

3. Episodes of Tachycardia/bradycardia/treatment

4. Episodes of Arrhythmia/treatment

5. ECG Changes

6. Pulmonary edema

7. Cardiac arrest

8. Any other adverse event 

OTHER DATA :

9. Vasopressin: concentration of drug in one ml of saline /amount of drug injected/speed & number(single/multiple) and duration of injection / injection by PG/Consultant /size of needle

10 .Blood loss

11 .Details of blood transfusion

                Also the incidence of hypotension, hypertension, bradycardia, tachycardia, arrhythmia, ECG changes and any adverse effects will be documented. The total amount of blood loss will be assessed by measuring the amount of blood in the suction bottle and visual estimation of gauze visual analogue. The primary outcome measured will be the safety of the drug vasopressin as assessed by the occurrence of any cardiovascular complications (arrhythmia, hypertension, myocardial ischemia, pulmonary edema). The secondary outcome measured will be the blood loss and requirements for blood transfusion.