A prospective randomized study to compare the efficacy of intravenous nalbuphine versus intravenous low dose ketamine for prevention of post spinal anaesthesia shivering

TITLE OF STUDY : PROSPECTIVE RANDOMIZED STUDY TO COMPARE THE EFFICACY OF INTRAVENOUS NALBUPHINE VERSUS INTRAVENOUS LOW DOSE KETAMINE FOR PREVENTION OF POST SPINAL ANAESTHESIA SHIVERING

Aim of the study : To compare the efficacy of intravenous nalbuphine and intravenous low dose ketamine in prevention of post spinal shivering in patients undergoing spinal anaesthesia.

Objectives of the study : 1.To compare the efficacy of drugs for INCIDENCE of post spinal shivering.

2. To compare the peri operative SHIVERING SCORE.

3. To compare the peri operative HEMODYNAMIC RESPONSE i.e. Heart rate (HR),

Non-invasive blood pressure (systolic blood pressure – SBP, diastolic

blood pressure – DBP and mean arterial pressure – MAP), Respiratory rate (RR),

Peripheral oxygen saturation (SpO2).

4. To compare the PERI OPERATIVE COMPLICATIONS, if any

Site of Study: Department of Anaesthesiology, Dhiraj Hospital, S.B.K.S. Medical Institute and Research Centre, Piparia, Waghodia, Vadodara, Gujarat.

Study Design- Prospective randomized comparative Study

Study Duration- The study will be initiated after obtaining the permission from institutional ethics committee till the achievement of the sample size or by 12 months whichever is earlier.

SAMPLE SIZE – 60 patients

Patients will be divided into 2 groups (Group N and Group K) of 30 patients each by computerised method.

Group N will receive Inj. Nalbuphine 0.1mg/kg intravenous (diluted till 10ml) 20 minutes after spinal anaesthesia.

Group K will receive Inj. Ketamine 0.5mg/kg intravenous (diluted till 10 ml) 20 minutes after spinal anaesthesia.

INCLUSION CRITERIA:

• Patients voluntarilly willing to sign informed consent.

• Male or female patients between 18 to 65 years of age.

• Patients with Body Mass Index less than 30 kg per m2

• Patients belonging to American Society of Anesthesiologists (ASA) physical status I and II.

• Patients posted for elective surgeries under spinal anaesthesia.

EXCLUSION CRITERIA:

• Patients unwilling to participate in the study.

• Patients with American society of Anesthesiiologist (ASA) physical status III, IV, V

• Patients with Body Mass Index equal to or more than 30 kg per m2.

• Patients with alcohol or other drug addiction.

• Patients in which spinal anaesthesia coverted to general anaesthesia.

• Patient with preexisting hoarseness or sore throat or upper respiratory tract infection.

• Patients with cardiovascular diseases, Neurological diseases, Spinal Deformities and patient on opioid medications.

• Patients with history of allergy to opioids.

• Pregnancy & lactating women

ETHICAL ISSUES :

Written informed consent from all patients will be obtained a day prior to surgery.

• Permission will be taken from the ethical committee before conducting the study.

• All the drugs and techniques used in our study are routinely used.

• Patients are not expected to bear any cost for the purpose of study.

• Any change in the methodology will be informed to the ethical committee.

• It is a prospective comparative randomized study.

• On finding of any adverse reaction or side effects in the participating patients, it will be brought to the attention of the ethical committee.

STATISTICAL ANALYSIS :

Data will be collected & tabulated. Numerical variables will be presented as mean &

standard deviation (SD) while categorical variables will be presented as frequency and

percentage. As regard to numerical variables; tests like unpaired student t test and/or

ANNOVA will be used whenever appropriate for between groups comparison s, while

for categorical variables; chi square test will be used. p value <0.05 will be considered

statistically significant.

FEASIBILITY ISSUES :

It is a comparative, prospective and randomized study.

• Patients will not be expected to bear any extra cost for the purpose of study.

• All the drugs and technique used in our study are routinely used and are readily available in pharmacy.

• The hospital being a tertiary set-up, with sufficient IPD patient, the study is feasible in our set-up.

LIKELY OUTCOME OR BENEFITS OF STUDY:

This prospective randomized comparative study will help us to compare the efficacy between intravenous nalbuphine and intravenous ketamine for prevention of post spinal shivering in patients undergoing surgeries under spinal anaesthesia and will enable us to know which drug is most beneficial in giving balanced thermoregulation by having better outcomes based on hemodynamics outcomes and less post-operative complications.