We are comparing how rocuronium and vecuronium will reduce the complications of succinylcholine by giving them before it.

Not yet recruiting

Conditions: Medical and Surgical,

Registration Number: CTRI/2019/10/021820

Lead Sponsor: B KRISHNA PREETHI

Brief Summary: **INTRODUCTION****:**

Ideal muscle relaxant for endotracheal intubation should have specificity, rapid onset of action,profound muscle relaxation,free from haemodynamic changes and rapid with complete recovery.

Succinylcholine is the ideal drug for endotracheal intubation after induction of anaesthesia. It has rapid onset of action and produces ideal intubating conditions. But it has undesirable side effects like fasciculations ,post operative myalgia, rise in intra-occular pressure, rise in serum potassium and serum creatinine phosphokinase levels and myoglobinuria. Many methods were tried earlier to decrease the side effects of succinylcholine, out of whichpre treatment with non-depolarising muscle relaxant is one.

In the present study , Rocuronium and Vecuronium will be tried to evaluate their efficacy as Pre-treatment before administration of succinylcholine.

**AIM AND OBJECTIVES:**

**AIM:**The aim of the study is to compare pre-treatment of Rocuronium and Vecuronium on post Succinylcholine  complications like fasciculations and post operative myalgia.

**PRIMARY OBJECTIVE**:

To reduce undesirable side effects of Succinylcholine like fasciculations and post operative myalgia.

**SECONDARY OBJECTIVE:**

To provide better intubating conditions.

**METHODOLOGY****AND MATERIAL:**

**Source of data**: Study will be conducted in Kalinga institute of medical sciences,PBMH, Bhubaneswar, Odisa.

**Study design:** Randomized double blind study.

**Sample size** **:**  Assuming with 80% power and 5% level of significance sample size is calcuated as140.

**Duration of study:** 2 years ( september2019 to september 2021)

**INCLUSION CRITERIA:**

1. Adult patients of either sex between 18-60yrs.

2. Patients of American society of Anaesthesiologists (ASA) grade I and II physical status.

3. Elective surgeries and the duration of surgery is minimum of 30min.

**EXCLUSION CRITERIA:**

1. BMI > 30

2. History of allergy to any particular drug used in the study

3. History of egg allergy

4. History of substance abuse

5. Pregnancy

6. Post burn, post trauma, and other hyperkalemic states

**RANDOMIZATION AND ALLOCATION:**

Randomization will be done by computer generated randomization list. Then the patients will be allocated to one of the two groups by the opaque sealed envelope technique and will receive either of the two drugs.

A double blind technique will be followed, where an anaesthesiologist who is not part of the study will prepare the drug according to the allocated group. The Rocuronium 0.06mg/kg or Vecuronium 0.01mg/kg will be diluted to 2 ml with normal saline. The drug will then be handed over to the investigator who will administer the drugs.

**A****NAESTHETIC TECHNIQUE :**

Standard anaesthetic techniques will be followed in all patients. All patients are pre medicated with   inj.Glycopyrrolate 0.2mg IV, inj.Midazolam1mg IV, inj.Nalbuphine 0.1mg/kg IV. The given drug will be injected to the patient .After 90secs  inj. Propofol 2mg/kg IV and inj.Succinylcholine  1.5mg/kg IV will be injected intravenously. Presence of post succinylcholine fasciculations intraoperatively, intubation conditions,post operative  myalgia on day 1,day 2 and day 3 will noted . Severity of fasciculation will be assessed on a four point scale (Foster 1960)2

No Fasciculations - Nil

Very fine only at finger tips and/or facial muscles - Mild

Minimal fasciculations on trunk and extremities - Moderate

Vigorous fasciculations on trunk and extremities - Severe

Intubation condition will be assessed (Lund 1970)3

| | | | |

| --- | --- | --- | --- |

|SCORE

JAW RELAXATION

VOCAL CORD POSITION

RESPONSE TO INTUBATION

|0

Poor

Closed

Severe coughing

|1

Minimum

Closing

Mild coughing

|2

Moderate

Moving

Slight diaphragmatic movements

|3

Good

Open

None

Intubating Condition Total Score:

Â² Excellent-- 8-9

Â² Good------- 6-7

Â² Fair --------3-5

Â² Poor-------- 0-2

Intra-operatively anaesthesia was maintained with oxygen, nitrous oxide, Isoflurane  and intermittent doses of Vecuronium. After completion of operative procedure, muscle relaxant will be reversed with Inj. Glycopyrlolate 10 mcg/kg, Inj. Neostigmine 50 mcg/kg. Patient will be extubated after complete recovery from effect of muscle relaxants, and shifted to recovery room.

  Myalgia  will be assessed on a four point scale (White 1962)4 on day1,day2,day3 post operative days.

1. NIL No muscle pain.

2. MILDMusle pain or stiffness with no limitation of activity.

3. MODERATE Muscle pain and/or stiffness all over body, but no limitation of activity.

4. SEVEREMuscle pain and stiffness with limitation of activity requiring treatment

**DISCUSSION:**All observations will be discussed with reference to currently available literature.

**CONCLUSION** **:** After reviewing the literature pertaining to the study, conclusion will be discussed in the final dissertation.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 140

Inclusion Criteria

INCLUSION CRITERIA: Adult patients of either sex between 18-60yrs.
Patients of American society of anaesthesiologists(ASA) grade I and II physical status.
Patient posted for elective surgeries under general anaesthesia of duration atleast 30min.

Exclusion Criteria

1.BMI > 30 2.History of allergy to any particular drug used in the study 3.History of egg allergy 4.History of substance abuse 5.Pregnancy 6.Post burn, post trauma, and other hyperkalemic states.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To reduce the undesirable side effects of succinylcholine like fasciculations and post operative myalgia.	INTRAOPERATIVELY 90 SECONDS AFTER GIVING SUCCINYLCHOLINE \| AND POST OPERATIVELY DAY 1 2 AND 3

Secondary Outcome Measures

Name	Time	Method
TO PROVIDE BETTER INTUBATING CONDITIONS INTRA OPERATIVELY.	60-90seconds after completion of succinylcholine action.

Trial Locations

Locations (1): Pradyumna bal memorial hospital.
🇮🇳
Khordha, ORISSA, India
Pradyumna bal memorial hospital.
🇮🇳Khordha, ORISSA, India
DR B KRISHNA PREETHI
Principal investigator
9618846462
doctorkrishnapreethi@gmail.com