To compare two drugs for reduction of propofol injection pain

Phase 4

Not yet recruiting

• Conditions: Medical and Surgical,

• Registration Number: CTRI/2021/06/034333
• Lead Sponsor: Department of Anaesthesia Panjab institute of medical sciences Jalandhar

Brief Summary

**AIMSAND OBJECTIVES**

 â—       The aim of thepresent study is to investigate the efficacy of pretreatment with 0.15mg/Kg   cisatracurium in the prevention of propol-associated pain injected 30s before propofol injection with venous occlusion athe forearm. The efficacy of cisatracurium will compared with that of 2%preservative free lidocaine

**MATERIAL AND METHODS**

•          Thisopen label prospective, randomized controlled study will be done at PIMS,Jalandhar after approval from institutional ethics committee on 80 patients(40patients for each group) scheduled to undergo elective non cardiac surgeryunder general anesthesia of ASA physical status I and II aged 18-65 years.

•       **Exclusion Criteria**: Patient refusal,Allergy to propofol or egg, limited neck mobility; history of difficultintubation; history of cardiovascular, respiratory, neurological, neuromuscularor psychiatric disease.

•      Patients will be randomly divided into two groupsaccording to computer generated randomization.

•      **Group-I:- Pretreatment with 2% Lignocaine 0.5mg/Kg(Preservative free)**

•      **Group-II: - Pretreatment with 0.15mg/Kg cisatracurium**.

•       Patient will be taken to the operative room andECG, SPO2, NIBP will be recorded.

•      A 20-G cannula will be inserted into the largestvisible vein on the radial side, attached to a three-way tap and flushed withRinger’s lactate solution.

•      A venous occlusion tourniquet will be applied justabove the elbow and pretreatment drug will be administered in open labelmanner. The tourniquet will be released after 30s. Then 0.5mg/kg propofol willbe delivered via the intravenous cannula. In order to evaluate pain anddetermine the possibility of muscle paralysis, patients will be asked “does ithurt?†by the anesthetist at 10s after the initial propofol dose, and at 20sintervals thereafter until unresponsive. Any spontaneous movement of the wrist,elbow or shoulder will be noted. Pain scores will be evaluated by ananesthetist who will be blinded to group assignment and expressed using afour-point scale:

**STATISTICAL ANALYSIS**

•      Continuous variables will be expressed as mean ±SD ormedian (range). Categorical variables were described as *n* (%).

•      Demographic data will be analyzed with one wayanalysis of variance and Scheffe’s post hoc test, or X2-test.

•       Between- groupvariation in the incidence of pain will be analyzed using X2-test.Statistical significant will be defined as P<0.05. Statistical analyses willperformed with SPSS.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2021-06-16
• Study Start: 2021-06-22

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients posted for elective surgery.

Exclusion Criteria

Patient refusal Allergy to propofol, egg History of cardiovascular, respiratory dysfunction History of difficult intubation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Efficacy of cisatracurium with 2% xylocard pretreatment to reduce propofol injection pain	Single

Secondary Outcome Measures

Name	Time	Method
Any adverse effects,(nausea, vomiting, muscle paralysis, diplopia, anaphylaxis) of both these drugs	Single
Any adverse effects (nausea , vomiting , muscle paralysis, diplopia, anaphylaxis) of cisatracurium and 2%xylocaine preservative free during study cisatracurium	Single

Trial Locations

Locations (2)

Department of Anaesthesia; 🇮🇳 Jalandhar, PUNJAB, India

Department of Anaesthesia Panjab institute of medical sciences Jalandhar; 🇮🇳 Jalandhar, PUNJAB, India

Department of Anaesthesia

🇮🇳Jalandhar, PUNJAB, India

Balwinderjit Singh

Principal investigator

drbalwinder2000@yahoo.co.in