Conscious sedation versus general anaesthesia for minilaparoscopic gamete intra-Fallopian transfer: a prospective randomized study

Massimiliano Pellicano1,2,4, Fulvio Zullo2,3, Agnese Fiorentino2, Giovanni A. Tommaselli1, Stefano Palomba1,3 and Carmine Nappi1

1 Department of Obstetrics, Gynecology and Reproductive Medicine, University of Naples ‘Federico II’, 2 Endogyn and Infertility Service, Private Gynecologic Associates, Naples and 3 Department of Gynecologic and Pediatric Sciences, University of Catanzaro, Catanzaro, Italy


    Abstract
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 Acknowledgements
 References
 
BACKGROUND: Gamete intra-Fallopian transfer (GIFT) is a successful technique for infertile women, and is performed almost exclusively by laparoscopy under general anaesthesia. METHODS: We performed a prospective randomized study of 67 infertile patients to assess the efficacy of minilaparoscopic GIFT under conscious sedation/local anaesthesia (group A) compared with general anaesthesia (group B). Operative and discharge times and pregnancy outcome were evaluated in both groups. RESULTS: Operative time was similar in both groups. The rate of patients discharged 2 h after surgery was significantly higher in group A. The necessity for postoperative analgesics was significantly higher in group B. No significant differences were noted between the two study groups in terms of pregnancy outcome. CONCLUSIONS: Conscious sedation and local anaesthesia will allow us to perform an outpatient minilaparoscopic GIFT without the need for general anaesthesia. The simplicity of the method, and the quicker discharge time in comparison with general anaesthesia, offer a detectable benefit for patients.

Key words: bupivacaine/conscious sedation/GIFT/local anaesthesia/minilaparoscopy


    Introduction
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 Acknowledgements
 References
 
The development of new small-diameter laparoscopes provides an optical view comparable with conventional instruments (Faber and Coddington, 1997Go) and some authors propose that minilaparoscopy should be used routinely for diagnostic laparoscopy (Kovacs et al., 1998Go). Moreover, the association of pre- and postoperative local anaesthesia (Narchi et al., 1991Go) and new protocols for conscious sedation (Almeida et al., 1997Go) should allow us to perform an outpatient minilaparoscopy without the use of general anaesthesia. Furthermore, reducing postoperative pain to a level at which narcotic analgesics are no longer required is an important step toward performing outpatient laparoscopic procedures (Wheatley et al., 1994Go). Postoperative pain control is even more relevant for patients undergoing outpatient diagnostic minilaparoscopy, in which the average time for discharge is 2–3 h following surgery (Pellicano et al., 1998Go).

Gamete intra-Fallopian transfer (GIFT) is a successful technique for the treatment of infertile women (Tournaye et al., 1996Go; Cramer et al., 2000Go). Originally, GIFT was performed by laparotomy and currently is performed almost exclusively by laparoscopy (Rombauts et al., 1997Go). Although most laparoscopic GIFT is actually done under general anaesthesia (Evans et al., 1999Go), some authors (Milki et al., 1992Go; Milki and Tazuke, 1997Go) report a significant cost containment and scheduling flexibility using local anaesthesia.

We conducted a prospective randomized study to evaluate the efficacy of minilaparoscopic GIFT performed under conscious sedation compared with general anaesthesia, in terms of operative and discharge time, and pregnancy outcome.


    Materials and methods
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 Acknowledgements
 References
 
Inclusion criteria for the study were: infertility duration >=2 years, three to six failed intrauterine insemination cycles, one patent tube following hysterosalpingography, normal uterine cavity following diagnostic hysteroscopy, no observation of pelvic pathology at ultrasound and no metabolic or cardiorespiratory disorders. Following informed consent, patients were randomly allocated to two study groups according to a computer-generated random assignment. In group A (n = 32), GIFT was performed by minilaparoscopy under local anaesthesia and conscious sedation. The control group (group B, n = 35) underwent GIFT using the same minilaparoscopic approach under general anaesthesia.

We did not seek Institutional Review Board approval for this study because conscious sedation and postoperative pain control are used routinely at our institutions for both diagnostic and minioperative minilaparoscopy.

Patients were down-regulated using leuprolide acetate depot 3.75 mg on day 22–24 of the previous cycle, and stimulated with 300 IU of purified FSH starting dose. Semen was prepared 2 h before surgery according to World Health Organization (WHO) guidelines (WHO, 1992Go). Transvaginal ultrasound guided aspiration of the oocytes was performed under conscious sedation in group A and under general anaesthesia in group B. Surgeons (M.P. or F.Z.) proceeded with the GIFT procedure. A mean of 3.8 oocytes were transferred in one tube.

In both groups a 3.5 mm lenses-optic endoscope (Wolf, Germany) with a 0-degree view was used. A 175-W Xenon light source, a new generation 3-CCD videocamera, a super-VHS videorecorder, and a high-definition monitor were used for the procedure.

Group A underwent minilaparoscopic GIFT using conscious sedation and local anaesthesia. Immediately before surgery, 0.5 mg atropine and 0.25 mg fentanyl was administered, followed by an i.v. slow injection of 2.0 mg midazolam (Ipnovel, Roche, Milan, Italy). After the cleansing of the abdomen, 10 ml of 1% mepivacaine was injected slowly beneath the umbilicus (gradually deeper down to the peritoneum) with a 10 ml syringe. After the subumbilical skin incision, a minitrocar was pushed directly into the peritoneum (Jacobson et al., 2000Go). The 3.5-mm miniendoscope was then inserted, insufflating about 1.2 l of CO2. A lateral ancillary site was anaesthetized using 10 ml of 1% mepivacaine gradually deeper down to the peritoneum. The patient was briefly put in a steep Trendelenburg position to bring back the intestine and then was reduced. Subsequently, the peritoneal cavity was inspected and a micrograsper was used to expose the fimbrial end of the Fallopian tube. The fimbriated end of the tube was gently elevated and the tube was cannulated to a distance of 3–4 cm. The GIFT catheter (Set de Frydman Long, Laboratoire CCD Paris, France) was passed through a guide in the abdomen on the midline, infiltrating the subcutaneous tissue with 5 ml of 1% mepivacaine. After the removal of trocars, the subcutaneous tissue of the insertion sites was injected with 5 ml of 0.5% bupivacaine (Marcaina, Astra Farmaceutici, Milan, Italy).

Postoperative analgesics were administered when requested by the patient and consisted of 100 mg of i.m. ketoprofene or 30 mg of i.m. ketorolac. Patients were monitored postoperatively in a recovery room for at least 2 h and discharged once free of discomfort.

In group B, minilaparoscopic GIFT was performed using the same endoscopic set-up and instruments, but using general anaesthesia. A preinduction dose of fentanyl (0.1 mg) was administered before i.v. induction of anaesthesia with propofol. Anaesthesia was maintained with continuous infusion of propofol and nitrous oxide in oxygen in a standardized manner.

Luteal phase supplementation was provided at a daily dose of 50 mg of i.m. progesterone (Prontogest; Amsa, Rome, Italy) starting the day after oocyte retrieval. Serum ß-human chorionic gonadotrophin (HCG) measurement and an ultrasound were performed 2 and 4 weeks respectively following GIFT procedure. Pregnancies were defined as clinical, ongoing, ectopic and miscarriage. Clinical pregnancy was defined as the ultrasound visualization of a gestational sac.

The operative time, the rate of patients discharged at 2 h and the pregnancy outcome were calculated in each group.

The inclusion of 30 women per group gave a statistical power of >80% for the discharge times. The statistical analysis was performed with the use of a commercial software program (STATISTICA for Windows, Statsoft, Inc, Tulsa, USA). Differences in age, infertility duration and body mass index (BMI) between groups were compared with the use of the two-tailed Student's t-test for unpaired data. Pregnancy parameters and the rate of patients discharged 2 h after surgery were evaluated by the {chi}2 test. Operative time differences between the groups and the mean discharge time were compared using the Wilcoxon rank sum test. P < 0.05 was defined as statistically significant.


    Results
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 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 Acknowledgements
 References
 
Eighty patients were initially enrolled in the study. Thirteen women dropped out of the study (eight in group A and five in group B). Thus 32 patients from group A and 35 from group B were considered as study patients.

Clinical data for patients included in the study are reported in Table IGo. The two groups did not differ in age, duration of infertility or BMI (Table IGo).


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Table I. Clinical data for 67 patients undergoing minilaparoscopic GIFT under conscious sedation (group A) or general anaesthesia (group B).
 
The operative time was not statistically different between group A (22.3 ± 5.1 min) and the control group (group B, 25.4 ± 7.3 min) (Table IIGo). The mean discharge time was significantly lower in group A (2.1 ± 0.6 h) compared with the control group (4.5 ± 2.3 h) (P < 0.001). The rate of patients discharged 2 h after surgery was significantly higher in group A (81.2%) (Table IIGo). The need for additional analgesics was significantly lower in group A (18.7%) compared with group B (54.2%) (P < 0.001) (Table IIGo).


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Table II. Operative and reproductive data for 67 minilaparoscopic GIFT performed under conscious sedation (group A) or general anaesthesia (group B)
 
Pregnancy outcome is reported in Table IIGo. No significant difference was observed in clinical pregnancy, ongoing and miscarriage rates between the two groups.

No complications from the administration of local anaesthesia were observed during the study.


    Discussion
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 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 Acknowledgements
 References
 
Through the years, the number of GIFT cycles has decreased in contrast with the increasing number of IVF procedures. In fact, GIFT is often not proposed due to the higher costs of general anaesthesia and operative setting, thereby ignoring its reported high success rates (Tournaye et al., 1996Go; Cramer et al., 2000Go; Daya , 2000Go).

The aim of the present study was to evaluate the efficacy of minilaparoscopic GIFT under conscious sedation compared with general anaesthesia in terms of operative and discharge time and pregnancy outcome.

Our previous studies reported the successful use of minilaparoscopy without general anaesthesia both in terms of diagnostic efficacy (Pellicano et al., 1998Go; Zupi et al., 1999Go) and for pain control during and after the procedure (Zullo et al., 1998Go). The recent development of small-diameter minilaparoscopy, which can provide an optical resolution comparable with that obtained with traditional laparoscopes (Faber and Coddington, 1997Go), combined with a significant improvement in sedation and local anaesthesia protocols (Zupi et al., 2000Go), should allow the use of outpatient minioperative procedures (Zullo et al., 2000Go).

The minimal invasiveness of the technique and the new conscious sedation/local anaesthesia protocols using low doses of midazolam permit the real possibility of an outpatient procedure with a quick patient discharge. Local anaesthesia has already been used for laparoscopic sterilization procedures (Bordhal et al., 1993Go) and for laparoscopic intra-Fallopian transfer (Milki et al., 1992Go; Milki and Tazuke, 1997Go) and it is well accepted by patients, is relatively cheap, ensures patient safety, and eases recovery in a day-surgery setting (Milki and Tazuke, 1997Go). Moreover, postoperative infiltration of the trocar sites with bupivacaine offers a detectable benefit to patients. This simple procedure appears to be particularly useful for outpatient minilaparoscopies in which the average discharge time is 2 h following the operation.

The durations of pneumoperitoneum and general anaesthesia have been reported to be negatively correlated with cleavage ratio and it may be advantageous to keep the procedure as short as possible (Bokhari and Pollard, 1998Go). However, many authors have reported no differences in terms of fertilization and cleavage ratios between conscious sedation and general anaesthesia in assisted reproduction techniques (Ben-Shlomo et al., 1999Go, 2000Go). Our minilaparoscopic approach allows reduction of the amount, and intraperitoneal pressure, of CO2 during surgery. Although we found no difference in terms of operative time and pregnancy outcome between groups, conscious sedation allows much reduced discharge times.

In conclusion, technical improvements such as smaller optic systems and improved anaesthetic procedures will permit the use of minilaparoscopy under local anaesthesia and conscious sedation to become the standard approach for GIFT. Outpatient minilaparoscopic GIFT under local anaesthesia with conscious sedation is flexible in schedule time, well accepted, and yields quick discharge times with pregnancy rates that are comparable with those of standard techniques. Moreover, minilaparoscopic GIFT can be performed in association with a diagnostic evaluation for a potential increase in cumulative pregnancy rates.


    Acknowledgements
 Top
 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 Acknowledgements
 References
 
We thank Wolf, Germany for the surgical equipment.


    Notes
 
4 To whom correspondence should be addressed at: Dipartimento di Ginecologia, Ostetricia e Fisiopatologia della Riproduzione Umana, Università di Napoli ‘Federico II’, Via Pansini, 5, 80131 Napoli, Italy. E-mail: pellican{at}unina.it Back


    References
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 Abstract
 Introduction
 Materials and methods
 Results
 Discussion
 Acknowledgements
 References
 
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Submitted on January 16, 2001; accepted on June 27, 2001.