Comparison of three drugs pethidine,butorphanol,dexmedetomidine for treatment of shivering under spinal anaesthesia

Recruiting

Conditions: ASA I/II/III

Registration Number: CTRI/2018/05/013684

Lead Sponsor: Bhagat Phool Singh Government Medical College For Women

Brief Summary: Shivering is one of themost common complications of a central neuraxial blockade, due to impairment ofthe thermoregulatory control. It has been reported in 40 to 70% of patientsundergoing surgery under regional anesthesia. Shivering, an oscillatory,involuntary muscular activity, is a physiological response to core hypothermiain an attempt to raise the metabolic heat production. Prolonged impairment ofthermoregulatory autonomic control under anaesthesia along with the coldenvironment of operating rooms and cold infusion fluids, contributes to a fallin core body temperature, and hence shivering. It increases the oxygen consumptionconsiderably and is uncomfortableand distressing to the patient,anaesthesiologist, as well as to the surgeon. Shivering also increasesintraocular and intracranial pressure, and may contribute to increased woundpain, delayed wound healing and delayed discharge from post-anaesthetic careunit. So, apart from being an uncomfortable experience, its deleterious effectswarrant primary prevention and prompt control. This study is designed toevaluate the efficacy of intravenous Pethidine, Butorphanol, Dexmedetomidinefor treatment of shivering under spinal anaesthesia. This is a randomizedprospective study and will be conducted in 150 patients of both genders withage between 18-60 years, ASA I, II & III who develop shivering under spinalanaesthesia during various orthopaedic, inguinal, abdominal, gynaecologicalprocedures. Cases will be randomly divided into 3 groups (Group P, B & D)with 50 patients in each group. Group P will receive injection pethidine 0.5 mg/kgintravenously, Group B will receive injection butorphanol 0.02 mg/kg intravenously and Group D willreceive 0.5 Âµg/kg of injection dexmedetomidine intravenously as soon asshivering is encountered after induction of spinal anaesthesia. The time ofinduction of spinal anaesthesia will be noted, grading of the shivering will be done , time of onset ofshivering, time at which study drug is given and time at which shivering ceaseswill be noted. We will also note axillary temperature at the time of onset ofshivering and and at cessation of shivering . Patients will also be observedintraoperatively for any variations in hemodyanamic parameters (heart rate,systolic and diastolic blood pressure, oxygen saturation ,respiratory rate).Wewill also take a note of any recurrent episode of shivering and incidence ofadverse effects like hypotension, bradycardia, nausea, vomiting, dizziness,somnolence, among the groups.

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: All

Target Recruitment: 150

Inclusion Criteria

1.Age 18-65 years( any gender) 2.American society of Anaesthesiologists (ASA) grade I , II &III physical status 3.Lower limb surgeries, inguinal, abdominal, urological and gynaecological procedures under spinal anaesthesia, who develop shivering during intra-operative and postoperative period (up to 2 hours) will be included in the study.

Exclusion Criteria

1.Patients with hypothyroidism or hyperthyroidism 2.Morbid Obesity (BMI> 40 kg/m2) 3.Fever (axillary temperature > 37 0 Celsius) 4.History of allergy to drugs.
5.Coagulation disorders 6.Patients with significant neurological, psychiatric, neuromuscular, cardiovascular, pulmonary, renal or hepatic diseases.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary outcome will be to compare the efficacy and response rates of pethidine, butorphanol and dexmedetomidine.	The time taken for cessation of shivering will be recorded at 1 minute interval till 5 min and thereafter upto 30 minutes.

Secondary Outcome Measures

Name	Time	Method
1.To monitor the vital parameters in all the three groups and compare them subsequently.	2.To record the incidence of recurrence in all the three groups.

Trial Locations

Locations (1): Bhagat Phool Singh Government Medical College For Women
🇮🇳
Sonipat, HARYANA, India
Bhagat Phool Singh Government Medical College For Women
🇮🇳Sonipat, HARYANA, India
Garima Sharma
Principal investigator
9582891320
garima.sharma01234@gmail.com