Comparison of lignocaine with placebo on control of blood pressure, heart rate and cough responses to tracheal extubation.

Not yet recruiting

• Conditions: Calculus of gallbladder without cholecystitis,

• Registration Number: CTRI/2021/09/036911
• Lead Sponsor: Sharda Hospital

Brief Summary

**1.    Introduction:**

Manytechniques and drugs have been proposed to blunt airway and haemodynamicresponses during tracheal extubationbut none have been completely successful.Tracheal extubation in deep plane is one such technique to blunt haemodynamicresponse and airway hyper-responsiveness, but, it increases the chances of airwayobstruction and aspiration. Other techniques to blunt such responses areendotracheal tube (ETT) exchange to laryngeal mask airway (LMA) and“No-Touch†extubation. Pharmacological therapies likelignocaine(intravenous, intra-cuff alkalinized, intra-cuff non-alkalinized, topical,endotracheal application), α-adrenergic agonists (clonidine, dexmedetomidine),β-adrenergic blockers (esmolol, labetalol), calcium-channel blockers(verapamil,diltiazem), vasodilators (nitroglycerin), opioids (remifentanil, fentanyl) andpropofol have been used to attenuate such responses, however, with variablesuccess rate and different side effects.

**In**

**DMethodology:**Inthis study,100 patientswill be randomly allocated into 4 groups in 1:1 ratio. Preoperatively,lignocaine (0.1 ml) will be injected subcutaneously in all the patients to testfor allergic reaction. The patients will be kept nil per oral for atleast 8hours prior to scheduled surgery. On the morning of surgery, all patients willreceive tablet ranitidine 150 mg orally with sips of water. Premedication willbe done with glycopyrrolate 0.2mg via intra muscular route 30 minutes prior tosurgery. Standard monitors such as non-invasive blood pressure (NIBP),electrocardiogram (ECG), and pulse oximetry (SpO2) will be attached.An intravenous cannula(18 or 20 G) will be inserted and patency will beconfirmed. After pre-oxygenation with 100% oxygen for 3 minutes, generalanaesthesia will be induced with fentanyl 2 mcg/kg IV and propofol 2-3 mg/kg IVtitrated to the loss of verbal responsiveness.Vecuronium 0.1 mg/kg IV will beadministered to facilitate tracheal intubation with a cuffed endotracheal tubehaving appropriate internal diameter. Ventilator settings will be done todeliver a tidal volume of 8 ml/kg and respiratory rate will be adjusted tomaintain an end-tidal carbon dioxide (EtCO2) value between 35-40mmof Hg (volume controlled ventilation). Maintenance of anaesthesia in all the 4groups will be done with oxygen and air (fraction of inspired oxygen being0.5), sevoflurane titrated to maintain minimum alveolar concentration (MAC)between 0.8-1.2 and intermittent doses of vecuronium (0.02 mg/kg IV).Anorogastric catheter will be inserted for gastric decompression after thetracheal intubation. Intraoperative body temperature will be maintained between36-37.5°C and will be monitored by a probe placed in the axilla. Intraoperativefluid therapy will be done with crystalloids and colloids, whenever required.Ondansetron (0.1 mg/kg IV) and paracetamol (1 gram IV over 15 minutes) will beadministered 30 minutes prior to completion of surgery. At the end of the surgery, sevoflurane willbe discontinued and fast alveolar washout will be done [discontinuingsevoflurane, flushing the breathing circuit with 100% oxygen and maintenance of100% oxygen at 10 litres/min] [25].Reversal of neuromuscular (NM) blockade willbe done with neostigmine (0.05-0.07 mg/kg IV) and glycopyrrolate (0.01 mg/kgIV) when train of four (TOF)count is atleast 2 or greater [26].

Anychange in HR and BP more than 20% of the pre-induction values during the periodfrom induction till completion of surgery will be treated with appropriatedrugs. Hypertension and/or tachycardia will be treated with 0.25 μg/kg ofintravenous fentanyl, if MAC is between 0.8-1.2within the study range. Patientsnot responding to fentanyl will be administeredintravenous labetalol inincremental doses of 5 mg. Hypotensive episodes will befirst managed with bolusof 200 ml crystalloids. In non-respondents, 3 mg of intravenous mephenterminewill be administered in incremental doses. Atropine (0.6 mg IV) will be usedfor bradycardia associated with hypotension.

**Group allocation, randomisation andblinding**

Inthis study, the patients will be randomised into four groups: group 1 (saline),group 2 (1mg/kg IV lignocaine), group 3 (1.5 mg/kg IV lignocaine) and group 4(2 mg/kg IV lignocaine) using a computer generated randomisation chart based onblock randomisation with variable size. Opaque sealed enveloped will be usedfor group allocation.The patients and the investigator will be blinded to thestudy drugs. Samples will be decoded for statistical analysis after thecompletion of the study.

**DDrug preparation and intervention**

Thestudy drugs will be prepared and labelled with sequential number (as perrandomisation chart) by an independent anaesthesiologist who is not involved inthe study. For blinding purpose, calculated dose of study drug will be dilutedto 5ml with saline in a 5cc syringe. The prepared drug will be handed over theinvestigator (anaesthesiologist conducting the case). After the administrationof the NM blocking reversal agent, the investigator will administer the studydrug when the patients open eyes to verbal commands and generates tidal volumeof atleast 6 ml/kg followed by the extubation of trachea after 90 seconds.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-04-10
• Last Update Posted: 2021-09-28

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1.American Society of Anaesthesiologists (ASA) physical status I and II 2.Age 18-60yrs 3.Scheduled for elective laproscopic cholecystectomy under general anaesthesia with tracheal intubation.

Exclusion Criteria

• 1.Refusal to consent 2.Morbid obesity 3.Pregnancy 4.Hypertension 5.History of coronary artery disease 6.
• History of chronic renal and hepatic disease 7.
• History of allergy to lignocaine 8.Seizure disorder, 9.Psychiatric disease, 10.Anticipated difficult airway.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Comparison of three different doses of intravenous lignocaine with placebo on attenuation of haemodynamic and airway responses to tracheal extubation in patients undergoing laparoscopic cholecystectomy under general anaesthesia.	Pre-induction, Just before the administration of study drug (T0), 1 min after extubation (T1), 2 mins after extubation (T2), 3 mins after extubation (T3), 4 mins after extubation (T4), 5 mins after extubation (T5), 10 mins after extubation (T10)

Trial Locations

Locations (1)

Sharda Hospital; 🇮🇳 Nagar, UTTAR PRADESH, India

Sharda Hospital

🇮🇳Nagar, UTTAR PRADESH, India

Shaista Jamil

Principal investigator

8750368756

docshaistajamil@gmail.com